Pharmacyclics

Sunnyvale, CA, United States

Pharmacyclics

Sunnyvale, CA, United States
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Additionally, researchers will present data from studies evaluating venetoclax, a BCL-2 inhibitor developed by AbbVie and Genentech, a member of the Roche Group, for investigational uses across multiple hematologic malignancies; ibrutinib, an inhibitor of Bruton's tyrosine kinase (BTK), across multiple hematologic malignancies and chronic graft versus host disease (cGVHD); rovalpituzumab tesirine (Rova-T), an investigational ADC targeting delta-like protein 3 (DLL3)-expressing tumors in small cell lung cancer (SCLC); veliparib, an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor, across multiple solid tumors; elotuzumab, an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein; and other early-stage investigational compounds. AbbVie will also share early-stage research from its oncology pipeline. AbbVie is utilizing technologies and new approaches to help advance cancer therapies that may become foundational to the next generation of cancer treatments. "AbbVie's data presentations at this year's ASCO meeting reinforce our diverse and comprehensive oncology pipeline, focused on bringing new medicines to patients, especially in areas where few options exist in cancer," said Tom Hudson, M.D., vice president of oncology discovery and early development, AbbVie. "By combining our deep knowledge in core areas of biology with cutting-edge technologies, and working together with our partners including scientists, industry peers and patients, we aim to discover and develop medicines that will drive transformational improvements in cancer treatment." The ASCO 2017 Annual Meeting abstracts are available at http://am.asco.org/abstracts. About IMBRUVICA® (ibrutinib) in the U.S. IMBRUVICA is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.5,6 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.5 IMBRUVICA is FDA-approved in five distinct patient populations: CLL, SLL, WM, along with previously-treated MCL and MZL. Accelerated approval was granted for the MCL and MZL indication based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.5 IMBRUVICA was one of the first medicines to receive U.S. Food and Drug Administration (FDA) approval via the new Breakthrough Therapy Designation pathway. IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry with nearly 30 company-sponsored trials underway, 14 of which are in Phase 3. In addition, there are approximately 100 investigator-sponsored trials and external collaborations that are ongoing and active around the world. To date, more than 65,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials. Patient Access to IMBRUVICA AbbVie and Janssen strive to make access to IMBRUVICA easy by helping patients in the U.S. understand their insurance benefits for IMBRUVICA. The YOU&i™ Support Program is a program that includes information on access and affordability support options, nurse call support and resources for patients being treated with IMBRUVICA. Hemorrhage - Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®. The mechanism for the bleeding events is not well understood. IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and postsurgery depending upon the type of surgery and the risk of bleeding. Infections - Fatal and nonfatal infections have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA®. Evaluate patients for fever and infections and treat appropriately. Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, 0% to 13%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA®. Monitor complete blood counts monthly. Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6% to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines. Hypertension - Hypertension (range, 6% to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new-onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®. Adjust existing antihypertensive medications and/or initiate antihypertensive treatment as appropriate. Second Primary Malignancies - Other malignancies (range, 3% to 16%) including non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 2% to 13%). Tumor Lysis Syndrome - Tumor lysis syndrome has been infrequently reported with IMBRUVICA® therapy. Assess the baseline risk (eg, high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate. Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period. The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia* (61%), thrombocytopenia* (62%), diarrhea (43%), anemia* (41%), musculoskeletal pain (30%), rash (30%), nausea (29%), bruising (30%), fatigue (29%), hemorrhage (22%), and pyrexia (21%). * Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased). The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MCL patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin infections (5%). The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MZL patients were pneumonia (10%), fatigue (6%), diarrhea (5%), rash (5%), and hypertension (5%). Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9% (WM [6%] and MZL [13%]) of patients discontinued due to adverse reactions. Most common adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash, and neutropenia (1% each) in CLL/SLL patients and subdural hematoma (1.8%) in MCL patients. The most common adverse reactions leading to discontinuation were interstitial lung disease, diarrhea, and rash (1.6% each) in WM and MZL patients. CYP3A Inhibitors - Avoid coadministration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose. Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose. About VENCLEXTA™ (venetoclax) in the U.S. Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor developed by AbbVie and Genentech, a member of the Roche Group, indicated in the U.S. for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. There is an ongoing study to find out how Venclexta works over a longer period of time. It is not known if Venclexta is safe and effective in children. Venclexta targets a specific protein in the body called BCL-2. When you have CLL, BCL-2 may build up and prevent cancer cells from self-destructing naturally. Venclexta targets BCL-2 in order to help restore the process of apoptosis. Through apoptosis, your body allows cancer cells and normal cells to self-destruct. AbbVie and Genentech are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory and first-line CLL, along with early phase studies in several cancers. Venetoclax is under evaluation by health authorities in multiple countries, and is currently approved in more than 10 nations, including the U.S. The full U.S. prescribing information for Venclexta can be found here. Patient Assistance Program For those who qualify, AbbVie and Genentech offer patient assistance programs for people taking Venclexta in the U.S. VENCLEXTA™ (venetoclax) U.S. Use and Important Safety Information Use What is VENCLEXTA™ (venetoclax)? VENCLEXTA™ (venetoclax) is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior treatment. VENCLEXTA was approved based on response rate. There is an ongoing study to find out how VENCLEXTA works over a longer period of time. It is not known if VENCLEXTA is safe and effective in children. Important Safety Information What is the most important information I should know about VENCLEXTA? VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your doctor will do tests for TLS. It is important to keep your appointments for blood tests. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Tell your doctor right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Who should not take VENCLEXTA? Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased. What should I tell my doctor before taking VENCLEXTA? Before taking VENCLEXTA, tell your doctor about all of your medical conditions, including if you: What should I avoid while taking VENCLEXTA? You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood. What are the possible side effects of VENCLEXTA? VENCLEXTA can cause serious side effects, including: The most common side effects of VENCLEXTA include low white blood cell count, diarrhea, nausea, low red blood cell count, upper respiratory tract infection, low platelet count, and feeling tired. VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your doctor if you have concerns about fertility. These are not all the possible side effects of VENCLEXTA. Tell your doctor if you have any side effect that bothers you or that does not go away. About Empliciti™ (elotuzumab) in the U.S. Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.7 Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity. On November 30, 2015, the U.S. Food and Drug Administration (FDA) approved Empliciti in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received one to three prior therapies. The safety and efficacy of Empliciti is still being evaluated by other health authorities. Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities. EMPLICITI™ (elotuzumab) is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in people who have received one to three prior treatments for their multiple myeloma. It is not known if EMPLICITI is safe and effective in children. EMPLICITI is used in combination with REVLIMID and dexamethasone. It is important to remember that the safety information for these medications also applies to EMPLICITI combination therapy. Before you receive EMPLICITI, tell your healthcare provider about all of your medical conditions, including if you: Serious side effects that can occur with EMPLICITI treatment are: The most common side effects of EMPLICITI include: These are not all of the possible side effects of EMPLICITI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please read Patient Information in the full Prescribing Information. About Depatuxizumab Mafodotin Depatuxizumab mafodotin, previously known as ABT-414, is an investigational antibody-drug-conjugate (ADC) being developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics.8 Depatuxizumab mafodotin is a biomarker-driven therapy that binds to an epitope that is exposed on tumor cells with epidermal growth factor receptor (EGFR) amplification and delivers a potent cytotoxin, a substance toxic to cells, that is released inside the tumor cell. It is being evaluated for EGFR-amplified newly diagnosed or recurrent glioblastoma (GBM), an aggressive malignant brain tumor.9 In 2014, the U.S. Food and Drug Administration (FDA) and the European Commission (EC) granted depatuxizumab mafodotin Orphan Drug Designation (ODD) for the treatment of GBM and glioma in adults, respectively.10,11 In 2016, the FDA granted depatuxizumab mafodotin Rare Pediatric Disease Designation for the treatment of diffuse intrinsic pontine glioma (DIPG), a type of pediatric brain tumor.12 Depatuxizumab mafodotin is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority. About Rovalpituzumab Tesirine (Rova-T) Rovalpituzumab tesirine (Rova-T) is an investigational antibody-drug conjugate (ADC) targeting delta-like protein 3 (DLL3), which is expressed in about 80 percent of small cell lung cancer (SCLC) patient tumors. It is prevalent on SCLC tumor cells, but not present in healthy tissue.13 Rova-T combines a targeted antibody with a cytotoxic agent to deliver a substance toxic to cells directly to the DLL3-expressing cancer cells. Rova-T is under investigation for the treatment of SCLC. An open-label, single-arm Phase 2 trial is under way to evaluate Rova-T in the third-line setting in relapsed or refractory DLL3-expressing SCLC.14 Two randomized Phase 3 trials have been initiated in the second-line and first-line maintenance setting. Additional studies are underway in multiple neuroendocrine tumor types, metastatic melanoma, and glioblastoma (GBM).15 Rova-T is an investigational compound and its efficacy and safety have not been established by the U.S. Food and Drug Administration (FDA) or any other health authority. About Veliparib Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types.16,17 PARP is a naturally-occurring enzyme in the body that repairs damage to DNA in cells. While this repair is a useful process to maintain the integrity of healthy cells, the same process may also help repair DNA in cancer cells, causing them to survive.18 Discovered and developed by AbbVie researchers, veliparib is being studied in combination with chemotherapy or radiation to help determine whether it can improve the survival outcome of common DNA-damaging therapies, such as chemotherapy or radiation, compared to platinum chemotherapy regimens alone.16 Veliparib is currently being studied in more than a dozen cancers, including in Phase 3 studies in advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), ovarian cancer and BRCA1/2 breast cancer.19 Veliparib is an investigational medicine and its efficacy and safety have not been established by the U.S. Food and Drug Administration (FDA) or any other health authority. About ABBV-221, ABBV-399 and ABT-348 ABBV-221 is an investigational epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC) being studied in an open-label, dose escalation Phase 1 clinical trial for the treatment of EGFR-expressing solid tumors in participants with advanced solid tumors likely to exhibit elevated levels of EGFR.20 ABBV-399 is an investigational c-Met targeted ADC being studied in an open-label Phase 1 clinical trial evaluating its safety, pharmacokinetics (PK) and preliminary efficacy in patients with solid tumors.21,22 ABT-348 is an investigational novel kinase inhibitor targeting the aurora, vascular endothelial growth factor receptor/platelet-derived growth factor receptor, and Src kinase families and is being studied in a Phase 2 clinical trial of patients with CDKN2A deficient solid tumors.23,24 These are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration (FDA) or any other health authority. About AbbVie in Oncology AbbVie is striving to outsmart cancer by working with scientists, physicians, industry peers, patient advocacy groups and most importantly patients, to discover, develop and provide new therapies that may have a remarkable impact on the lives of people around the world affected by cancer. Our goal is to provide medicines that make a transformational improvement in cancer treatment and outcomes for cancer patients. By exploring and investing in new pathways, technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers. We are also exploring solutions to help patients obtain access to our cancer medicines. With the acquisition of Pharmacyclics in 2015 and Stemcentrx in 2016, and through several collaborations, AbbVie's oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly 200 clinical trials in 20 different tumor types. For more information about AbbVie Oncology, please visit http://abbvieoncology.com. About Pharmacyclics, An AbbVie Company Pharmacyclics LLC, a wholly-owned subsidiary of AbbVie (NYSE: ABBV), is focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune-mediated diseases. Pharmacyclics' mission is to develop and commercialize novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs. Pharmacyclics markets IMBRUVICA and has two product candidates in clinical development and several preclinical molecules in lead optimization. Pharmacyclics is committed to high standards of ethics, scientific rigor and operational efficiency as it moves each of these programs toward commercialization. To learn more, please visit www.pharmacyclics.com. About AbbVie AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn. AbbVie Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 Ostrom QT, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2009–2013. Neuro Oncol. 2016;18:v1-v75. 2 Visser O, et al. Survival of adults with primary malignant brain tumours in Europe; Results of the EUROCARE-5 study. Eur J Cancer. 2015 [Epub ahead of print]. 3 Brennan CW, et al. The somatic genomic landscape of glioblastoma. Cell. 2013;155:462-477. 4 Yoshimoto K, et al. Development of a real-time RT-PCR assay for detecting EGFRvIII in glioblastoma samples. Clin Cancer Res. 2008;14:488-493. 5 IMBRUVICA US Prescribing Information, January 2017. 6 Genetics Home Reference (2017). Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed March 2017. 7 Empliciti [Package Insert]. Princeton, N.J.: Bristol-Myers Squibb Company. 8 Van den Bent M, et al. ACTR-07. Efficacy of a novel antibody-drug conjugate (ADC), ABT-414, as monotherapy in epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM). Neuro Oncol. 2016; 18. 9 Omuro A, et al. Glioblastoma and other malignant gliomas: A clinical review. JAMA. 2013;310(17):1842-1850. 10 AbbVie Inc. ABT-414 Sponsor Briefing Document. Pediatric Oncology Subcommittee. November 19, 2015. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM472970.pdf. Accessed March 2017. 11 U.S. Food and Drug Administration (2014). Orphan Drug Designations and Approvals. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=433214. Accessed March 2017. 12 Warren KE, et al. Diffuse intrinsic pontine glioma: poised for progress. Front Oncol. 2012;2:205. 13 Saunders LR, et al. A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumor-initiating cells in vivo. Sci Transl Med. 2015;7(302):1-13. 14 ClinicalTrials.gov (2017). NCT02674568: Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer (TRINITY). https://clinicaltrials.gov/ct2/show/NCT02674568?term=NCT02674568&rank=1. Accessed March 2017. 15 ClinicalTrials.gov (2017). Search Results: Rovalpituzumab Tesirine. https://clinicaltrials.gov/ct2/results?term=Rovalpituzumab+Tesirine+&Search=Search. Accessed March 2017. 16 Palma JP, et al. ABT-888 confers broad in vivo activity in combination with temozolomide in diverse tumors. Clin Cancer Res. 2009;15(23):7277-7290. 17 Anders CK, et al. Poly (ADP-Ribose) polymerase inhibition: "targeted" therapy for triple-negative breast cancer. Clin Cancer Res. 2010;16(19):4702-4710. 18 Plummer ER, et al. Targeting Poly (ADP-Ribose) Polymerase: A Two-Armed Strategy for Cancer Therapy. Clin Cancer Res. 2007;13(21): 6252-6256. 19 ClinicalTrials.gov (2017). Results: Veliparib: Open Studies. https://clinicaltrials.gov/ct2/results?term=veliparib&recr=Open. Accessed March 2017. 20 Calvo, et al. Preliminary Results from a Phase 1 Study of the Antibody-Drug Conjugate ABBV-221 in Patients with Solid Tumors Likely to Express EGFR. Abstract 2510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT. 21 Angevin, et al. Phase I Study of ABBV-399, a c-Met Antibody-Drug Conjugate (ADC), as Monotherapy and in Combination with Erlotinib in Patients (Pts) with Non-Small Cell Lung Cancer (NSCLC). Abstract 2509; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT. 22 Awad, et al. Impact of MET Inhibitors on Survival Among Patients (Pts) with MET Exon 14 Mutant (METdel14) Non-Small Cell Lung Cancer (NSCLC). Abstract 8511; Clinical Science Symposium; Sunday, June 4, 2017; 8:00 a.m.-9:30 a.m. CDT. 23 Maitland, et al. Pharmaco-kinetics/dynamics (PK/PD) Evaluation and Individual Patient Cross-Over Studies with Growth Trajectory Assessment to Adaptively Develop Ilorasertib. Abstract 2563; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT. 24 ClinicalTrials.gov (2017). NCT02478320: Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors. https://clinicaltrials.gov/ct2/show/NCT02478320. Accessed May 2017. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbvie-to-present-latest-clinical-study-results-in-hematology-and-solid-tumor-research-at-the-53rd-american-society-of-clinical-oncology-asco-annual-meeting-300459531.html


News Article | May 9, 2017
Site: www.businesswire.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today the appointment of several experienced industry leaders to key leadership roles including: Manmeet S. Soni, Chief Financial Officer; Theresa Heggie, Senior Vice President, Head of Europe and Canada; Peter Smith, Ph.D., Senior Vice President, Early Development; and Alan Eisenberg, Vice President, Global Public Policy and Government Relations. "We are thrilled to welcome Manmeet, Theresa, Peter, and Alan to Alnylam at an exciting moment in our history. Each of these individuals brings a critical set of skills to the organization as we transition from a late-stage research and development company to a multi-product, commercial-stage company with a robust and sustainable pipeline of innovative medicines,” said John Maraganore, Ph.D. Chief Executive Officer of Alnylam. "This expansion of our leadership team solidifies and strengthens our path forward." “I couldn’t imagine a more exciting time to join Alnylam,” said Mr. Soni. “It’s an honor to have the opportunity to work with such a talented group of individuals focused on bringing forward a new class of medicines for the betterment of lives of patients in need. I look forward to using my experience in building and leading commercial finance teams and capabilities to help Alnylam execute on its strategy, goals and transition towards an independent commercial-stage company.” In this role Mr. Soni will provide strategic leadership in the overall financial management of Alnylam, including for the global finance, investor relations and communications teams. Manmeet is the former Chief Financial Officer and Treasurer of ARIAD Pharmaceuticals, Inc., where he played a central role in the strategic review, turnaround and subsequent acquisition of ARIAD Pharmaceuticals, Inc. by Takeda Pharmaceuticals Company Limited. Before joining ARIAD Pharmaceuticals, Inc., Manmeet worked at Pharmacyclics, Inc., where he served most recently as Chief Financial Officer and Treasurer. Mr. Soni also played a vital role in the acquisition of Pharmacyclics, Inc. by Abbvie, Inc. for $21 billion. Previously, Mr. Soni worked at ZELTIQ Aesthetics Inc., and PricewaterhouseCoopers San Jose, in the Life Science and Venture Capital Group. Prior to that, he worked at PricewaterhouseCoopers, India. Mr. Soni is currently a board member and audit committee chair at Genoscience Pharma. He graduated from Hansraj College at Delhi University in India. He is a Certified Public Accountant, licensed in the state of California and a Chartered Accountant from India. "Expanding Alnylam’s operations into Europe and Canada is being done in recognition of the broad commercial rights we have in these regions and the important role they will play in our global commercial strategy," commented Ms. Heggie. "Drawing on my expertise from numerous European and global leadership roles, I look forward to advancing this important phase of the Company’s commercial evolution and bringing new treatments to patients in Europe and Canada." In this role Ms. Heggie will be responsible for the strategic direction and activity of all of Alnylam’s operations in Europe and Canada including building the go-to-market strategy across multiple products and therapeutic areas. Most recently she served as the Chief Marketing and Strategy Officer at The British United Provident Association (Bupa). Previously, Ms. Heggie held various senior commercial positions at Shire Human Genetic Therapies (and formerly TKT) including the roles of Vice President and General Manager of EMEA, Chief Executive Officer of Jerini AG (a Shire acquisition), and Senior Vice President of Global Commercial Operations. Earlier, at Baxter Healthcare she held numerous roles including Vice President of Global Marketing. Early in her career, Ms. Heggie held a variety of sales and marketing positions at Janssen Pharmaceuticals. She formerly served as a member of the board of directors of Swedish Orphan Biovitrum AB. Theresa received a BSc from Cornell University. Ms. Heggie will report to Barry Greene, President and will be based at Alnylam’s European headquarters in Zug, Switzerland. “Having the ability to work at an organization with a product engine as productive as Alnylam’s is a very special opportunity,” added Dr. Smith. “The ability to grow and develop the Early Development team across the pipeline of RNAi therapeutics at Alnylam will be paramount as we advance the translation of promising science toward new medicines for patients.” In this role, Dr. Smith will be responsible for all aspects of non-clinical safety, drug metabolism and pharmacokinetics, bioanalysis and biomarker programs, providing both scientific and drug development leadership. Dr. Smith brings more than 30 years of pharma industry experience to Alnylam, most recently joining from Moderna, where he was Head of R&D Non-Clinical. He joined Moderna from Millennium Pharmaceuticals, where he most recently served as co-head of R&D and a member of the company’s management team. In this role, he was responsible for management of all Non-Clinical groups and Pharmaceutical Sciences. His extensive experience in drug discovery and development spans multiple therapeutic areas and therapeutic modalities. Over the course of Dr. Smith’s career, he has had oversight of the non-clinical development of multiple, currently marketed therapeutics including CELEBREX®, INSPRA®, VELCADE® and ENTYVIO®, and also deep involvement in the development of numerous other products. Dr. Smith has a B.S. in biology from Fairfield University and a Ph.D. in Pharmacology and Toxicology from the University of Arizona. His postdoctoral fellowship in biochemical toxicology was undertaken at SmithKline. He has published and presented extensively in the pharm/tox area as well as in the area of drug development. Dr. Smith will report to Akshay Vaishnaw, Executive Vice President of Research and Development. “In an era of intense scrutiny around value and access to innovation, I look forward to drawing on my political and policy experience both in the private and public sectors to help Alnylam achieve its objectives,” said Mr. Eisenberg. “I’m deeply aligned with the mission and vision of Alnylam and look forward to working on behalf of the company with our governmental stakeholders globally.” In this role, Alan will lead federal, state and local government affairs and public policy initiatives globally. Alan joins Alnylam from Celgene where he was the Vice President for Federal Government Relations. In this role, he led Celgene’s Federal Government Relations function and had direct responsibility for the Company’s public policy engagement with Congress, relevant Executive Branch agencies and other Washington, D.C. based stakeholders. Prior to Celgene, Mr. Eisenberg was Executive Vice President for Emerging Companies & Business Development at the Biotechnology Innovation Organization (BIO), leading BIO’s services and advocacy efforts for BIO’s pre-market and early stage commercial companies, in addition to serving in other senior leadership roles at BIO. Previously, Mr. Eisenberg served as Health and Economics Policy Advisor to Congressman Jim Greenwood and prior to that, he served on the staff of the Senate HELP Public Health Subcommittee, and also was a legislative assistant for Congressman John Shadegg. Earlier in his career he spent four years with Ford Motor Company. Mr. Eisenberg holds a Master in Public Policy degree from Harvard University, a Master of Science in Finance degree from George Washington University, and a Bachelor of Science degree from Union College. Mr. Eisenberg will report to Laurie Keating, Senior Vice President and General Counsel. Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment options. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically-validated approach for the treatment of a wide range of debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust discovery platform and deep pipeline of investigational medicines, including three product candidates that are in late-stage development or will be in 2017. Looking forward, Alnylam will continue to execute on its “Alnylam 2020” strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam. Various statements in this release concerning Alnylam's future expectations, plans and prospects, including, without limitation, Alnylam's views with respect to the potential for RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, Alnylam's ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all, actions or advice of regulatory agencies, including actions by regulators concerning product candidates, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, Alnylam's ability to enforce its intellectual property rights against third parties and defend its patent portfolio against challenges from third parties, obtaining and maintaining regulatory approval, pricing and reimbursement for products, progress in establishing a commercial and ex-United States infrastructure, competition from others using technology similar to Alnylam's and others developing products for similar uses, Alnylam's ability to manage its growth and operating expenses, obtain additional funding to support its business activities, and establish and maintain strategic business alliances and new business initiatives, Alnylam's dependence on third parties for development, manufacture and distribution of products, the outcome of litigation, the risk of government investigations, and unexpected expenditures, as well as those risks more fully discussed in the "Risk Factors" filed with Alnylam's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.


News Article | February 17, 2017
Site: www.prnewswire.co.uk

The board of directors of AbbVie Inc. (NYSE: ABBV) has authorized a $5 billion increase to AbbVie's existing stock repurchase program. Purchases may be made from time to time in management's discretion. The stock repurchase authorization permits shares to be repurchased in open market or private transactions, has no time limit and may be discontinued at any time. AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs approximately 30,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page. This is a disclosure announcement from PR Newswire.


News Article | November 2, 2016
Site: www.prnewswire.co.uk

AbbVie (NYSE: ABBV) today announced that it has mandated Barclays, BofA Merrill Lynch, Deutsche Bank, J.P. Morgan and Morgan Stanley (Global Coordinator) to organize a series of European fixed income investor meetings, commencing on Wednesday, November 9, 2016. An inaugural EUR-denominated senior unsecured multi-tranche benchmark transaction to refinance indebtedness will follow, subject to market conditions. AbbVie intends to use the proceeds of any offering together with existing cash on hand to repay all or a part of its 1.75% Senior Notes that mature on November 6, 2017. Relevant stabilization regulations including FCA/ICMA will apply. This announcement does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of such securities under the securities law of any such jurisdiction. This announcement is not being made, and this announcement has not been approved, by an authorized person for the purposes of section 21 of the United Kingdom Financial Services and Markets Act 2000, as amended (the "FSMA").‎ Accordingly, this announcement is not being distributed to, and must not be passed on to, the general public in the United Kingdom or to persons in the United Kingdom save in circumstances where section 21(1) of the FSMA does not apply. This announcement is made to and is directed only at persons in the United Kingdom having professional experience in matters relating to investments who fall within the definition of "investment professionals" in Article 19(5) or are high net worth companies, unincorporated associations etc. falling within Article 49(2), in each case of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, and to those persons to whom it can otherwise lawfully be distributed (all such persons together being referred to as "relevant persons"). This announcement and the securities referred to herein are, and will be made, available only to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, such relevant persons. No other person should rely or act upon it. This announcement is not intended for distribution to and must not be passed on to any retail client. The company has filed a shelf registration statement (including a prospectus) with the U.S. Securities and Exchange Commission (the "SEC"). Any offering of securities will be made only by means of a prospectus supplement, which will be filed with the SEC. In the event that the company proceeds with an offering, you may obtain a copy of the prospectus supplement and accompanying prospectus for the offering by visiting EDGAR on the SEC website at www.sec.gov, or from the company or the underwriters of that offering by contacting Barclays at 1-888-603-5847, BofA Merrill Lynch at 1-800-294-1322, Deutsche Bank at 1-800-503-4611, J.P. Morgan collect at +44-207-134-2468 and Morgan Stanley at 1-866-718-1649. AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view our Facebook and LinkedIn pages. This is a disclosure announcement from PR Newswire.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genentech and Bristol-Myers Squibb (BMS) lead oncology franchises in image and engagement according to oncologists, who give them top scores across multiple metrics. Merck, Novartis, Amgen and Celgene rank in the second tier, with eight additional companies rounding out the field. In specific tumor areas, Genentech is the frontrunner in breast cancer, colorectal cancer and chronic lymphocytic leukemia. BMS is perceived as the leader in melanoma and lung cancer, and Celgene leads in multiple myeloma. Across several tumor areas, checkpoint inhibitors such as PD-1 and PD-L1 emerge as game changers in 2016 and over the next five years in the minds of physicians. These and other findings (including hematologist perceptions) are from Pharma Engage® a Cogent Reports study released by Market Strategies International. “It’s critical for pharmaceutical companies to engage with physicians across a variety of settings to foster strong relationships, yet motivating physicians to engage is not always easy,” said Caroline Brennan, Ph.D., vice president of the Life Sciences division at Market Strategies. “We found that likelihood to engage with a manufacturer is strongly linked to image, so firms can increase physician engagement by improving their image.” According to Brennan, “having a relevant product portfolio is the number one driver of image. However, that does not mean the smaller firms are out of luck. It simply means they need to focus on other attributes that will improve their image, such as innovative R&D and HCP educational resources. Each company has its own set of priority levers, and companies that don’t invest in them will have a tougher time establishing meaningful engagement.” “It’s particularly important to note that the companies being noticed for making great strides in immunotherapy and other novel mechanisms of action are also the ones rising to the top in image within specific tumor types,” she added. “It will be interesting to see how future discoveries impact image moving forward.” Cogent Reports conducted an online study among 157 office-based oncologists and 103 hematologists who were recruited from a national online panel in November 2016. To qualify, physicians needed to be board-certified and were required to have a minimum number of oncology patients, spend at least 50%–60% of their time in patient care and have exposure to sales representatives. This study evaluates and ranks Amgen, Astellas, AstraZeneca, Bayer, BMS, Celgene, Genentech, J&J/Janssen, Lilly, Merck & Co, Novartis, Otsuka, Pfizer and Takeda on: The study also examines leadership across six key tumor areas: breast, lung, colorectal, melanoma, CLL and multiple myeloma. Companies vary by tumor type and include a relevant subset of the companies above as well as AbbVie, Gilead, Incyte, Medivation, Pharmacyclics, Prometheus, Sanofi and Teva, where applicable. Market Strategies International is a market research consultancy with deep expertise in health, consumer & retail, energy, financial services, technology and telecommunications. We blend primary research with data from our syndicated, benchmarking and self-funded studies as well as Big Data to provide clients with the most complete and accurate insights needed to make confident business decisions. Market Strategies’ research specialties include brand, communications, CX, product development and segmentation. Our syndicated products, known as Cogent Reports, help clients understand the market environment, explore industry trends and monitor their brand and products within the competitive landscape. Founded in 1989, Market Strategies is one of the largest market research firms in the world, with offices in the US, Canada and China. Read Market Strategies’ blog at FreshMR, and follow us on Facebook, Twitter and LinkedIn.


"Over the past few years, we've seen tremendous improvements in the treatment of people with CLL and SLL. Newly introduced medications can improve the outcome of therapy, particularly for patients with high-risk prognostic markers who typically do not respond well to standard chemotherapy," said Thomas J. Kipps, M.D., Ph.D., University of California San Diego, Moores Cancer Center and lead investigator of the study.† "Analysis of the clinical data suggests an improvement in outcomes for certain high-risk CLL/SLL patients treated with IMBRUVICA." CLL is a type of cancer that starts from cells that become certain white blood cells (called lymphocytes) in the bone marrow. The cancer (leukemia) cells start in the bone marrow but then go into the blood. There are approximately 19,000 newly diagnosed CLL patients every year.1 SLL is a slow-growing lymphoma biologically similar to CLL in which too many immature white blood cells cause lymph nodes to become larger than normal.2 CLL/SLL are predominately a disease of the elderly, with a median age of 71 at diagnosis.3 Genomic abnormalities in CLL, including del 11q, deletion 17p (del 17p), trisomy 12, CK and IGHV, are detected in up to 80 percent of patients and play an important role in disease pathogenesis and evolution, determining patient outcomes and therapeutic strategies.6 "We are encouraged by the findings from these analyses, which add to the large body of data supporting IMBRUVICA in treating CLL/SLL patients," said Danelle James, M.D., M.S., Head of Clinical Science, Pharmacyclics LLC, an AbbVie company. "We have one of the most robust databases for a single molecule in hematological oncology and more than 25,000 CLL patients have been treated in the U.S. alone with IMBRUVICA since approval in 2014. We continue to investigate the use of IMBRUVICA in high-risk patients so that ideally they too can achieve better response rates and overall outcomes to treatment." Abstract #19: Outcomes of Ibrutinib-Treated Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL) with High-Risk Prognostic Factors in an Integrated Analysis of 3 Randomized Phase 3 Studies Data from three studies, RESONATE, RESONATE-2 and HELIOS, were pooled to analyze the outcomes of IMBRUVICA and comparator-treated patients when separated on the basis of genomic abnormality. The ORR in patients treated with IMBRUVICA was 89 percent in unmutated IGHV, 88 percent in del 11q, 86 percent in trisomy 12 and 87 percent in CK, with patients achieving a CR rate of 22 percent in unmutated IGHV, 18 percent in del 11q, 25 percent in trisomy 12 and 10 percent in CK. At 24 months, in patients treated with IMBRUVICA, PFS was 78 percent in unmutated IGHV, 82 percent in del 11q, 77 percent in trisomy 12 and 76 percent in CK. In patients treated with IMBRUVICA, at 30 months, OS was 88 percent in unmutated IGHV, 93 percent in del 11q, 89 percent in trisomy 12 and 84 percent in CK.3 In each subgroup, PFS, OS, ORR and CR rates trended higher in IMBRUVICA-treated patients versus comparator-treated patients, regardless of genomic factors. In IMBRUVICA-treated patients, unmutated IGHV, del 11q, trisomy 12 or CK were generally not associated with shorter PFS or OS, or decreased ORR or CR rate. Further, in IMBRUVICA-treated patients, del 11q was associated with a trend of longer PFS (82 percent at 24 months for those with del 11q, compared with 75 percent for those without del 11q) and OS (93 percent at 30 months for those with del 11q, compared with 86 percent for those without del 11q) and trisomy 12 with increased CR rate (25 percent for those with trisomy 12, compared with 6 percent for those without trisomy 12). In a multivariate analysis, ibrutinib-treated patient outcomes in those only having received one or more prior lines of therapy versus treatment in the first-line was associated with shorter PFS and OS.3 In RESONATE, patients received IMBRUVICA 420 mg once daily until disease progression or ofatumumab for up to 24 weeks. In RESONATE-2, patients age 65 or older with treatment-naïve CLL/SLL, not including del 17p, received IMBRUVICA 420 mg once daily until disease progression, or chlorambucil. In HELIOS, a Janssen-sponsored, randomized, multi-center, double-blind study, previously treated CLL/SLL patients were randomized to receive IMBRUVICA or placebo, once daily continuing until disease progression or unacceptable toxicity with six cycles of BR.3 Adverse events (AEs) were similar in patients with or without genomic factors, and reflect a median treatment exposure of 19-20 months for IMBRUVICA-treated patients and 5-10 months for comparator-treated patients. Discontinuation due to AEs ranged from 8-15 percent in IMBRUVICA-treated patients and 13-17 percent in comparator-treated patients.3 P-values ranged from 0.03-0.96. To view more abstract data, including all P-values, see Table 1 and Table 2 at the end. About IMBRUVICA IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.4,5 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.4 IMBRUVICA is FDA-approved in five distinct patient populations: CLL, SLL, WM, along with previously-treated MCL and MZL.4 Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.4 IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway. IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with approximately 130 ongoing clinical trials. There are total of 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and approximately 100 investigator-sponsored trials and external collaborations that are active around the world. To date, more than 65,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials. Hemorrhage - Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®. The mechanism for the bleeding events is not well understood. IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and postsurgery depending upon the type of surgery and the risk of bleeding. Infections - Fatal and nonfatal infections have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA®. Evaluate patients for fever and infections and treat appropriately. Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, 0% to 13%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA®. Monitor complete blood counts monthly. Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6% to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately and if it persists, consider the risks and benefits of IMBRUVICA® treatment and follow dose modification guidelines. Hypertension - Hypertension (range, 6% to 17%) has occurred in patients treated with IMBRUVICA® with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new-onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA®. Adjust existing antihypertensive medications and/or initiate antihypertensive treatment as appropriate. Second Primary Malignancies - Other malignancies (range, 3% to 16%) including non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 2% to 13%). Tumor Lysis Syndrome - Tumor lysis syndrome has been infrequently reported with IMBRUVICA® therapy. Assess the baseline risk (eg, high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate. Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA® and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period. The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia** (61%), thrombocytopenia** (62%), diarrhea (43%), anemia** (41%), musculoskeletal pain (30%), rash (30%), nausea (29%), bruising (30%), fatigue (29%), hemorrhage (22%), and pyrexia (21%). ** Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased). The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MCL patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin infections (5%). The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MZL patients were pneumonia (10%), fatigue (6%), diarrhea (5%), rash (5%), and hypertension (5%). Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9% (WM [6%] and MZL [13%]) of patients discontinued due to adverse reactions. Most common adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash, and neutropenia (1% each) in CLL/SLL patients and subdural hematoma (1.8%) in MCL patients. The most common adverse reactions leading to discontinuation were interstitial lung disease, diarrhea, and rash (1.6% each) in WM and MZL patients. CYP3A Inhibitors - Avoid coadministration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose. Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose. About AbbVie AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn. Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. †Disclaimer: Dr. Kipps served as investigator of Pharmacyclics-sponsored clinical studies as noted.Dr. Kipps does not have a financial interest in the company. Table 2. Efficacy Outcomes in Ibrutinib- and Comparator-Treated Patients by Genomic Prognostic Factors (Univariate) To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/imbruvica-ibrutinib-pooled-outcomes-data-from-three-phase-3-studies-suggest-potential-clinical-efficacy-in-patients-with-high-risk-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-300457242.html


(San Diego, December 6, 2016) - A late-breaking abstract being presented today during the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego shows patients who experience graft-versus-host disease (GVHD) after stem cell transplantation that is not resolved by corticosteroid treatment may benefit from the use of ibrutinib, an anti-cancer drug approved by the U.S. Food and Drug Administration for treating certain blood cancers. Sixty-seven percent of the trial's 42 participants who experienced GVHD responded to ibrutinib, and 71 percent showed sustained improvements with ibrutinib over a five-month period, results that are encouraging for a subset of patients with limited treatment options beyond corticosteroids, according to the researchers. "This is a very high response rate," said lead study author David Miklos, MD, of Stanford University. "These data are remarkable, and ibrutinib appears to exceed the therapeutic benefits of other agents. I think clinicians will find these data support the use of ibrutinib in patients with steroid refractory chronic GVHD (cGVHD), who currently suffer a range of symptoms that can be chronic and debilitating." Ibrutinib is designed to kill certain types of cancer cells by inhibiting the enzyme Bruton's tyrosine kinase (BTK). The new trial and pre-clinical laboratory studies suggest the drug's BTK inhibition activity and its inhibition of interleukin-2-inducible T-cell kinase (ITK) also make it a potent weapon against two types of immune cells -- T-cells and B-cells -- that are involved in GVHD. The researchers enrolled 42 patients who had undergone allogeneic stem cell transplantation, a procedure in which blood-forming stem cells are taken from a donor and injected into a patient to help replace blood cells that have been lost due to cancer or cancer treatments. About 10,000 people receive allogeneic stem cell transplants in the United States each year. Of these, about 4,000 subsequently experience GVHD, in which the transplanted stem cells attack the patient's body, causing symptoms such as rashes, mouth ulcers, dry eyes, gastrointestinal problems, shortness of breath, and decreased mobility in the joints and limbs. Immune-suppressing corticosteroid medications are the standard treatment for GVHD, but they do not benefit all patients. The patients in this trial showed sustained GVHD symptoms despite corticosteroid treatment. Five months after initiating treatment with ibrutinib, 71 percent experienced meaningful clinical improvements as indicated by decreases in clinician and patient assessments of symptom severity, a reduction in the number of organs affected, and analysis of biomarkers associated with GVHD. A substantial proportion of participants -- 45 percent -- experienced serious adverse events such as pneumonia, septic shock, or severe fever. Additional adverse events included fatigue, diarrhea, muscle spasms, nausea, and bruising. The researchers said these findings are in line with what had been reported in prior studies and underscore the importance of actively monitoring and managing any adverse events when prescribing ibrutinib. Overall, the researchers said ibrutinib represents a promising potential new therapy for GVHD. "By targeting allogeneic B-cells and TH2 lymphocytes, ibrutinib is targeting a pathogenic mechanism that we believe causes GVHD while leaving protective and anti-tumor cytotoxic T-cells intact," said Miklos. "This is a targeted therapy that does not just bluntly suppress the immune system; it leaves patients better able to fight their cancer as well as viral infections." The researchers and their collaborators are currently recruiting participants for several additional trials to further investigate the use of ibrutinib in preventing or treating GVHD and compare it to other agents. The study was funded by Pharmacyclics, LLC, an AbbVie Company, which makes ibrutinib. David Miklos, MD, Stanford University, Stanford, Calif., will present this study, titled "Multicenter Open-Label Phase 2 Study of Ibrutinib in Chronic Graft Versus Host Disease (cGVHD) after Failure of Corticosteroids,"(LBA-3) during the late-breaking abstracts session on Tuesday, December 6 at 7:30 a.m. PST in Hall AB. For the complete annual meeting program and abstracts, visit http://www. . Follow @ASH_hematology and #ASH16 on Twitter and like ASH on Facebook for the most up-to-date information about the 2016 ASH Annual Meeting. The American Society of Hematology (ASH) (http://www. ) is the world's largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 50 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. The Society publishes Blood (http://www. ), the most cited peer-reviewed publication in the field, as well as the newly launched, online, open-access journal, Blood Advances (http://www. ).


BEERSE, Belgique--(BUSINESS WIRE)--Janssen-Cilag International NV a annoncé les résultats du plus long suivi réalisé à ce jour pour des patients suivant un traitement à l'Imbruvica®▼ (ibrutinib) contre la leucémie lymphoïde chronique (LLC), faisant état de réponses élevées et durables sur cinq ans.1 Ces données mises à jour de Phase 1b/2 ont montré un taux de réponse globale (TRG) de 89%,2 y compris les patients avec des mutations génétiques associées à des pronostics médiocres. Une réponse complète (RC) a été observée chez 29% des patients traités en première ligne.2 La survie sans progression de la maladie (SSPM) s'est améliorée en lançant plus tôt le traitement chez les patients naïfs de traitement (NT) et les patients en rechute ou réfractaires (r/r).2 Ces données (résumé #2331) ont été présentées samedi 3 décembre lors d'une présentation orale2 prononcée à la 58e conférence et exposition annuelles de l'American Society of Hematology (ASH) à San Diego, en Californie. Les données du suivi chez les patients atteints de LLC et traités à l'ibrutinib pendant 29 mois à partir de la Phase 3 de l'essai RESONATE-2 ont également été présentées samedi (résumé #2343). L'ibrutinib, inhibiteur de premier ordre de la tyrosine kinase de Bruton (BTK), est développé conjointement par Cilag GmbH International (une filiale de Janssen) et Pharmacyclics/AbbVie. Les filiales de Janssen commercialisent l’ibrutinib dans la région EMOA (Europe, Moyen-Orient et Afrique) ainsi que dans le reste du monde, à l’exception des États-Unis, où les deux sociétés assurent une commercialisation conjointe. « Ces résultats à plus long terme démontrent que l'ibrutinib peut aider les patients atteints de leucémie lymphoïde chronique à rester dans un état de rémission complète ou partielle sur une longue période de cinq années, sans chimiothérapie », déclare Susan O’Brien, DG, directrice adjointe des Sciences cliniques, au Chao Family Comprehensive Cancer Center de l'UC Irvine Health, directrice médicale, au Sue and Ralph Stern Center for Clinical Trials & Research, et chercheur et présentatrice des essais PCYC-1102 et PCYC-1103.* « De plus, ces données indiquent que la durée sans progression de la maladie est plus longue lorsque le traitement à l'ibrutinib est démarré le plus tôt possible. » Dans ces études (PCYC-1102 et PCYC-1103), avec cinq années de suivi, le TRG chez les patients traités à l'ibrutinib était de 89%,2 avec 14% des patients atteignant une réponse complète (RC)2 [TRG de 87% avec 29% de RC chez les patients NT (n=31) et TRG de 89% avec 10% de RC chez les patients r/r (n=101)].2 La durée médiane d'étude était de 62 mois (1-67) pour les patients NT2 et de 49 mois (1-67) pour les patients r/r.2 La survie globale (SG) à cinq ans était de 92% pour les patients NT et de 57% pour les patients r/r, avec un taux respectif de SSPM de 92% et 43%.2 La SG médiane et la durée de réponse médiane n'ont pas été atteintes. La SSPM médiane n'a pas été atteinte pour les patients NT, et était de 52 mois pour les patients r/r.2 Les résultats étaient cohérents chez les patients r/r atteints de LLC à risque élevé, et les facteurs de risques ont traditionnellement été associés à des pronostics médiocres4 y compris pour ceux avec délétion 11q (del11q; n=28), délétion 13q (del13q; n=13), délétion 17p (del17p; n=34) et une région variable de chaîne lourde d'immunoglobuline non mutée (IGHV; n=79).2 La SSPM médiane était de 55 mois (31-NE) pour ceux avec del11q, 26 mois (95% CI, 18-37) pour ceux avec del17p, 43 mois (95% CI, 32-non estimable) pour ceux avec une IGHV non mutée, et n'a pas était atteinte pour ceux avec del13q.2 Les résultats ont indiqué que la SSPM et la SG étaient supérieures lorsque le traitement à l'ibrutinib démarré plus tôt.2 La SSPM médiane n'a pas été atteinte chez les patients NT2 et était de 63 mois pour les patients r/r qui avaient déjà reçu un ou deux régimes médicamenteux,2 de 59 mois pour ceux qui avaient déjà reçu trois régimes,2 et de 39 mois pour ceux qui avaient déjà reçu quatre régimes ou plus.2 « Les preuves irréfutables en faveur des avantages de l'ibrutinib pour les patients continuent d'arriver, et ces données à plus long terme, pendant cinq années de traitement anti LLC, sont une importante confirmation des effets durables qui peuvent être obtenus avec l'ibrutinib », souligne Jane Griffiths, présidente du groupe Janssen Europe, Moyen-Orient et Afrique. « Grâce à ces améliorations cliniques significatives, nous sommes heureux de modifier l'horizon thérapeutique et les diagnostics pour les patients atteints de LLC. » Aucun nouveau signal d'innocuité n'a été constaté durant l'étude.2 L'apparition d'effets indésirables en cours de traitement de niveau trois ou supérieur, pour tous les patients, était plus élevée au cours de la première année et a diminué avec le temps. Les effets indésirables les plus fréquents ont été l'hypertension (26%), la pneumonie (22%), la neutropénie (17%) et la fibrillation auriculaire (9%).2 La Phase 1b/2 de l'essai PCYC-1102 a évalué l'innocuité et l'efficacité de l'ibrutinib en monothérapie chez 132 patients atteints de LLC: 31 patients étaient NT: 101 étaient r/r.2 Les patients ont reçu 420 mg ou 840 mg une fois par jour jusqu'à progression de la maladie ou jusqu'à un niveau de toxicité inacceptable.2 Parmi les patients r/r, 34% étaient del17p, 35% del11q, 47% del13q et 78% IGHV non mutée.2 Le critère principal était le TRG, et les critères secondaires étaient la durée de réponse et la SSPM, en plus de l'innocuité. La PCYC-1103 est l'étude d'extension longue durée. Les résultats primaires de cet essai avaient été publiés dans The New England Journal of Medicine en juin 20135 et ont servi de base à l'approbation initiale de l'ibrutinib aux États-Unis pour les patients atteints de LLC en février 2014 avec l'obtention de la Breakthrough Therapy Designation.6 Résumé #234: Efficacité et innocuité mises à jour pour la Phase 3 de l'étude RESONATE-2: l'ibrutinib en tant qu'option thérapeutique de première ligne pour les patients âgés de 65 ans et plus atteints de leucémie lymphoïde chronique3 Les résultats mis à jour de l'étude pivot RESONATE-2 de Phase 3 (PCYC-1115) ont démontré qu'à une moyenne de 29 mois de suivi, l'ibrutinib continuait d'avoir une efficacité substantielle en tant que thérapie de première ligne contre la LLC. Selon l'étude, l'ibrutinib a réduit de 88% le risque de progression ou de décès en comparaison avec le chlorambucil, un agent de chimiothérapie communément utilisé. À 24 mois, la SSPM était de 89% pour les patients prenant de l'ibrutinib et de 34% pour le chlorambucil [HR, 0,121; 95% CI 0,074-0,198; p<0,0001). Le TRG évalué par les chercheurs pendant ce suivi de plus longue durée était de 92% avec l'ibrutinib et de 36% avec le chlorambucil ; avec l'ibrutinib, les RC ou RC avec rétablissement médullaire incomplet ont connu une amélioration, passant de 15% à 24 mois, à 18% avec un suivi de 29 mois. Les résultats d'innocuité étaient conformes avec l'analyse primaire de l'étude, et ont démontré que les effets indésirables de niveau 3 ou supérieur ont diminué avec le temps. La plupart des effets indésirables qui ont conduit à un abandon thérapeutique se sont produits durant la première année de traitement. Les effets indésirables de niveau ≥ 3 les plus fréquents (≥5%) étaient la neutropénie (12%), la pneumonie (7%), l'anémie (7%) et l'hypertension (5%). RESONATE-2 est une étude en cours de Phase 3, sponsorisée par Pharmacyclics, randomisée, multicentrique et ouverte, réalisée auprès de 269 patients naïfs de traitement et atteints de LLC, âgés de 65 ans et plus, dans l'UE, aux États-Unis et dans d'autres régions. Les patients ont été randomisés pour recevoir de l'ibrutinib 420 mg par voie orale, une fois par jour jusqu'à progression ou toxicité inacceptable, ou du chlorambucil les jours 1 et 15 de chaque cycle de 28 jours et jusqu'à 12 cycles. La dose de départ de chlorambucil pendant le Cycle 1 était de 0,5 mg/kg et a été augmentée en fonction de la tolérabilité pendant le Cycle 2 par paliers de 0,1 mg/kg jusqu'à un maximum de 0,8 mg/kg. L'étude a validé son critère principal en démontrant une amélioration de la SSPM, telle qu'évaluée par un comité d'évaluation indépendant. Les résultats initiaux de RESONATE-2 avaient été présentés au cours d'une session orale à la conférence de l'American Society of Hematology (ASH) en décembre 20158 et publiés simultanément dans The New England Journal of Medicine.7 La LLC est une maladie chronique ; la durée de survie globale médiane varie entre 18 mois et plus de 10 ans en fonction du stade de la maladie.12 La maladie évolue finalement chez la majorité des patients, et les patients ont à chaque fois un nombre plus réduit d’options de traitement. On prescrit souvent aux patients de multiples lignes de traitement lorsqu’ils rechutent ou deviennent résistants aux traitements. Dans les sociétés pharmaceutiques Janssen du groupe Johnson & Johnson, nous œuvrons à créer un monde sans maladie. Transformer les vies en trouvant des moyens nouveaux et meilleurs pour prévenir, intercepter, traiter et guérir les maladies est pour nous une source d'inspiration. Nous réunissons les plus brillants esprits et recherchons la science la plus prometteuse. Nous sommes Janssen. Nous collaborons dans le monde entier au service de la santé de tous. Pour en savoir plus, rendez-vous sur www.janssen.com. Suivez-nous sur www.twitter.com/janssenEMEA pour connaître toute notre actualité. Le présent communiqué de presse contient des « énoncés prospectifs » au sens de la loi Private Securities Litigation Reform Act de 1995 pour ce qui concerne le développement de produits. Il est conseillé au lecteur de ne pas placer une confiance excessive dans ces énoncés prospectifs. Ces énoncés sont fondés sur les attentes actuelles par rapport à des événements futurs. Si les suppositions sous-jacentes s’avèrent inexactes ou si des risques ou incertitudes, connus ou inconnus, se matérialisent, les résultats réels pourraient différer sensiblement des attentes et projections de Janssen-Cilag International NV et/ou de Johnson & Johnson. Les risques et incertitudes incluent, sans toutefois s’y limiter : les défis et incertitudes inhérents au développement de produits, y compris l’incertitude quant à la réussite clinique et à l’obtention des autorisations réglementaires ; l’incertitude quant au succès commercial ; la concurrence, y compris les progrès technologiques, les nouveaux produits et brevets obtenus par nos concurrents ; les difficultés ou retards dans la fabrication ; la contestation de brevets ; les préoccupations concernant l’efficacité ou l’innocuité de produits résultant de rappels de produits ou d’actions réglementaires ; les modifications des comportements et des habitudes d’achat ou les difficultés financières des acheteurs de produits et de services de soins de santé ; ainsi que les tendances envers la maîtrise des coûts des soins de santé. Une liste et une description plus exhaustives de ces risques, incertitudes et autres facteurs figurent dans le rapport annuel de Johnson & Johnson sur formulaire 10-K pour l’exercice clos au 3 janvier 2016, notamment dans la partie 99 de celui-ci, et dans les documents déposés ultérieurement par la société auprès de la Commission américaine des opérations de Bourse (la « SEC »). Des exemplaires de ces documents sont disponibles en ligne sur www.sec.gov, www.jnj.com ou sur demande auprès de Johnson & Johnson. Aucune des sociétés pharmaceutiques Janssen, ni Johnson & Johnson n’assume l’obligation de mettre à jour un quelconque énoncé prospectif suite à de nouvelles informations ou à des événements ou développements futurs. 1. O’Brien S, Furman R, Coutre S, et al. Five-Year Experience with Single-Agent Ibrutinib in Patients with Previously Untreated and Relapsed/Refractory Chronic Lymphocytic Leukemia. Oral presentation at the 58th Annual Meeting and Exposition of the American Society of Hematology, San Diego, USA, 3-6 December 2016: Abstract #233. Presented on 3 December 2016. Disponible sur: https://ash.confex.com/ash/2016/webprogram/Paper89757.html. Dernière consultation novembre 2016. 2. O’Brien S, Furman R, Coutre S, et al. Five-Year Experience with Single-Agent Ibrutinib in Patients with Previously Untreated and Relapsed/Refractory Chronic Lymphocytic Leukemia. Oral presentation at the 58th Annual Meeting and Exposition of the American Society of Hematology, San Diego, USA, 3-6 December 2016. Presented on 3 December 2016. 3. Barr P, Robak T, Owen C, et al. Updated Efficacy and Safety from the Phase 3 Resonate-2 Study: Ibrutinib As First-Line Treatment Option in Patients 65 Years and Older with Chronic Lymphocytic Leukemia. Oral presentation at the 58th Annual Meeting and Exposition of the American Society of Hematology, San Diego, USA, 3-6 December 2016: Abstract #234. Disponible sur: https://ash.confex.com/ash/2016/webprogram/Paper89615.html. Dernière consultation novembre 2016. 5. Byrd J, Furman R, Coutre S, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369:32-42. 6. Johnson & Johnson. IMBRUVICA™ (ibrutinib) Now Approved in the U.S. for Patients with Chronic Lymphocytic Leukemia Who Have Received At Least One Prior Therapy. Press release, 12 February, 2014. Disponible sur: http://www.investor.jnj.com/releasedetail.cfm?releaseid=825570. Dernière consultation novembre 2016. 7. Burger J, Tedeschi A, Barr P, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015:373:2435-37. 8. Janssen. Ibrutinib (IMBRUVICA®) Significantly Improved Progression-Free and Overall Survival Versus Chlorambucil in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia. Press release, 6 December 2015. Disponible sur: http://www.janssen.com/ibrutinib-imbruvica-significantly-improved-progression-free-and-overall-survival-versus-chlorambucil. Dernière consultation novembre 2016. 9. O’Brien S, et al. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet Oncol. 2014;15:48-58.

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