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Rubin E.H.,Merck And Co. | Allen J.D.,Friends of Cancer Research | Nowak J.A.,NorthShore University Health System Pathology and Laboratory Medicine | Bates S.E.,U.S. National Cancer Institute
Clinical Cancer Research | Year: 2014

Advances in understanding the biology of cancer, as well as advances in diagnostic technologies, such as the advent of affordable high-resolution DNA sequencing, have had a major impact on the approach to identification of specific alterations in a given patient's cancer that could be used as a basis for treatment selection, and hence the development of companion diagnostics. Although there are now several examples of successful development of companion diagnostics that allow identification of patients who will achieve the greatest benefit from a new therapeutic, the path to coapproval of a diagnostic test along with a new therapeutic is complex and often inefficient. This review and the accompanying articles examine the current state of companion diagnostic development in the United States and Europe from academic, industry, regulatory, and economic perspectives.©2014 American Association for Cancer Research.


Horning S.J.,Genentech | Haber D.A.,Massachusetts General Hospital | Haber D.A.,Howard Hughes Medical Institute | Selig W.K.D.,Melanoma Research Alliance | And 6 more authors.
Clinical Cancer Research | Year: 2013

In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential "breakthrough" drugs or treatments that show dramatic responses in early-phase studies. Using this regulatory pathway, once a promising new drug candidate is designated as a "Breakthrough Therapy", the U.S. Food and Drug Administration (FDA) and sponsor would collaborate to determine the best path forward to abbreviate the traditional three-phase approach to drug development. The breakthrough legislation requires that an FDA guidance be drafted that details specific requirements of the bill to aid FDA in implementing requirements of the Act. In this article, we have proposed criteria to define a product as a Breakthrough Therapy, and discussed critical components of the development process that would require flexibility in order to enable expedited development of a Breakthrough Therapy. © 2013 American Association for Cancer Research.


Fridlyand J.,Genentech | Simon R.M.,U.S. National Cancer Institute | Walrath J.C.,Friends of Cancer Research | Roach N.,Fight Colorectal Cancer | And 6 more authors.
Nature Reviews Drug Discovery | Year: 2013

As diagnostic tests become increasingly important for optimizing the use of drugs to treat cancers, the co-development of a targeted therapy and its companion diagnostic test is becoming more prevalent and necessary. In July 2011, the US Food and Drug Administration released a draft guidance that gave the agency's formal definition of companion diagnostics and introduced a drug-diagnostic co-development process for gaining regulatory approval. Here, we identify areas of drug-diagnostic co-development that were either not covered by the guidance or that would benefit from increased granularity, including how to determine when clinical studies should be limited to biomarker-positive patients, defining the diagnostically selected patient population in which to use a companion diagnostic, and defining and clinically validating a biomarker signature for assays that use more than one biomarker. We propose potential approaches that sponsors could use to deal with these challenges and provide strategies to help guide the future co-development of drugs and diagnostics. © 2013 Macmillan Publishers Limited. All rights reserved.


Hayes D.F.,University of Michigan | Allen J.,Friends of Cancer Research | Compton C.,Critical Path Institute | Gustavsen G.,Health Advances | And 9 more authors.
Science Translational Medicine | Year: 2013

Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable tests stems from a vicious cycle of undervaluation, resulting from inconsistent regulatory standards and reimbursement, as well as insuf cient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility. We of er recommendations designed to serve as a roadmap to break this vicious cycle and call for a national dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders. Copyright © 2013, American Association for the Advancement of Science.


Herbst R.S.,Yale University | Gandara D.R.,University of California at Davis | Hirsch F.R.,Aurora University | Redman M.W.,Fred Hutchinson Cancer Research Center | And 22 more authors.
Clinical Cancer Research | Year: 2015

The Lung Master Protocol (Lung-MAP, S1400) is a groundbreaking clinical trial designed to advance the efficient development of targeted therapies for squamous cell carcinoma (SCC) of the lung. There are no approved targeted therapies specific to advanced lung SCC, although The Cancer Genome Atlas project and similar studies have detected a significant number of somatic gene mutations/amplifications in lung SCC, some of which are targetable by investigational agents. However, the frequency of these changes is low (5%-20%), making recruitment and study conduct challenging in the traditional clinical trial setting. Here, we describe our approach to development of a biomarker-driven phase II/II multisubstudy "Master Protocol,"using a common platform(next-generation DNA sequencing) to identify actionable molecular abnormalities, followed by randomization to the relevant targeted therapy versus standard of care. ©2015 American Association for Cancer Research.

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