Three major proposals to help move new cancer therapies faster through the development process were presented at the Conference on Clinical Cancer Research last week in Washington, DC.
The conference, now in its fifth year, is hosted by Friends of Cancer Research and the Engelberg Center for Health Care Reform at Brookings, and supported by ASCO, American Association for Cancer Research, and Susan G. Komen for the Cure. Leaders in cancer drug development from federal health and regulatory agencies, academic research, and the private sector met for a year prior to the conference to develop the proposals that address key issues surrounding the development and regulation of cancer therapies.
The three proposals were developed by the following panels:
● “Developing Standards for Breakthrough Therapy Designation,” chaired by ASCO member Charles Sawyers, MD, of Memorial Sloan-Kettering Cancer Center, proposes criteria for the new breakthrough designation for approval created by the 2012 Prescription Drug user Fee Act.
● “Design of a Disease-Specific Master Protocol,” chaired by ASCO member Roy Herbst, MD, of Yale Cancer Center, proposes an alternative to traditional trial design for a phase III registration trial testing multiple new therapies simultaneously. Dr. Herbst also serves on ASCO’s Cancer Research Committee.
● “Re-evaluating Criteria for Accelerated Approval,” chaired by ASCO member Richard Schilsky, MD, of University of Chicago Medical Center, proposes broadening FDA’s definition of an unmet medical need that would allow a sponsor to apply for accelerated approval for a therapy, and describes the evidence required for qualification of a new surrogate endpoint for accelerated approval. In addition to being immediate-past chair of ASCO’s Government Relations Committee, Dr. Schilsky will join ASCO in February 2013 as Chief Medical Officer.
Further information on the proposals can be found in the papers linked above. The panels plan to revise the proposals based on input from the meeting and submit for peer-reviewed publication.
Other ASCO members who were panelists included Sandra Horning, MD, of Genentech; Jeffrey Abrams, MD, of the National Cancer Institute; Eric Rubin, MD, of Merck; and David Schenkein, MD, of Agios Pharmaceuticals.
Harold Varmus, MD, director of the National Cancer Institute, and Janet Woodcock, MD, of the Food and Drug Administration, gave keynote speeches.
For further information, visit the Friends of Cancer Research event page.