FDA to allow development and testing of drug combinations for cancer

August 30, 2010

A new understanding of cancer and the intertwined mechanisms and pathways involved, has led scientists to consider ways to attack the disease on multiple fronts.  This involves development of drug combinations, but in the past, FDA rules required that each active drug be evaluated and tested through Phase III trials before it could be combined with another drug.  The FDA is changing course and is now set to introduce new guidelines for the testing and approval of combination drug products for cancer therapy.  The new guidelines will be posted for public comment before approval and will describe three basic requirements, according to a news article published in The San Francisco Chronicle.  There should be a scientific rationale for how the drugs will work in the body; there should be evidence from mouse tests or small human trials that the benefit of combining the drugs is more than additive; and there should be a compelling reason why each drug can't be successful independently.

According to the article, several pharmaceutical companies have combination therapies in the works and expect this approach to cause a "radical change in terms of stopping this disease in its tracks."  Pfizer and Roche are developing the needed parts in their own labs, whereas Novartis, Merck, GlaxoSmithKline, and AstraZeneca are each collaborating with other companies to combine drugs and co-develop.