2010 CCCR FDA Guidance | Friends of Cancer Research

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2010 CCCR FDA Guidance

FDA Releases Guidance Based on Friends of Cancer Research and Brookings Institution Conference

Each year Friends of Cancer Research (Friends) and the Engelberg Center for Health Care Reform at Brookings convene the Conference on Clinical Cancer Research to develop a clear path forward on key issues surrounding the development and regulation of cancer drugs and therapies.


The 2009 conference included a panel titled: Development of Rational Drug Combinations with Investigational Targeted Agents (Conference White Paper Available Here).  The panel examined specific situations for which a large, four-arm phase 3 clinical trial could be modified. The panel proposed criteria and potential development plans that would generate the desired data on the combination as well as the individual agents.  Rational drug combinations have the potential for greater efficacy in oncology areas as well as other disease settings.

In March of 2010 Friends of Cancer Research submitted a draft guidance to the FDA (Available Here). The guidance document addressed the unique challenges surrounding development of therapies involving two (or more) new molecular entities (2NMEs).

On December 14th 2010, the FDA released a draft guidance document (Available Here) that mirrors the 2009 panel, subsequent white paper, and submitted draft guidance. This was the product of a great deal of collaborative work between many individuals and organizations. 


Media Coverage of Draft Guidance:

Wall Street Journal- FDA: Here’s How to Develop Drug Combinations

The move has been in the works for a while. Some of the regulatory challenges involved in developing combination therapies were highlighted at a September 2009 panel hosted by the Brookings Institution and the Friends of Cancer Research.

Over the next year, draft guidelines were developed, and they’re now open for public comment for the next 60 days. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research told the group of venture capitalists, drug company executives, and foundation representatives at today’s meeting that if companies want to work together, they shouldn’t wait for the final guidelines to be issued.

The Pink Sheet - FDA Draft Co-Development Guidance Emphasizes Phase II Studies

During her remarks at the Faster Cures meeting, Woodcock acknowledged the cancer think tank Friends of Cancer Research, which submitted a draft guidance to the agency in March based on a September 2009 stakeholder conference the group convened along with the Brookings Institution. The FDA draft's scenarios for narrowing study designs before Phase III look a lot like the proposal in the report of that meeting. 

FDA's draft is reflective of the agency's willingness to engage scientific experts from stakeholder communities, Jeff Allen, Friends executive director, said in an interview. "We took up the subject because it is completely biologically plausible that this is the way forward in cancer research, as well as in other areas" specified in the guidance. But raising the issue isn't as important as defining the path forward, "and I think the guidance does a very good job of adding some additional advice on tough questions," Allen said.

Historically, "cancer research has in many ways been a serial experimentation of adding standard of care plus new, and we're moving to much more of a biologically driven model where we'll be able to examine which pathways are malfunctioning and design the targeted therapies" for types of cancer, he said. "FDA certainly recognizes that this is the future of targeted medicine."

Massachusetts Medical Device Journal- FDA wants home runs from drug combinations

FDA Center for Drug Evaluation and Research head Janet Woodcock encouraged an audience made up of venture capitalists, pharmaceutical executives and heads of foundations to not wait for the FDA's final guidelines before they begin their drug combination development. The agency wants companies to conduct lab and animals studies that demonstrate that the combination therapy is more effective or provides a longer response compared to either of the drugs. "We're looking for the home run here," Woodcock said.

The guidelines were drafted subsequent to a September 2009 panel hosted by think tanks Friends of Cancer Research and the Brookings Institution.