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WASHINGTON — In 2000, the Food and Drug Administration approved just three cancer drugs. Last year, even with the agency laser-focused on the coronavirus pandemic, much of its staff teleworking, the agency still approved a record-breaking 17 different cancer therapies — more than in any other category.

That’s the legacy of FDA drug center chief Janet Woodcock.


Woodcock, a 36-year veteran of the agency, is infamous for pushing the FDA to loosen its standards for drugs for rare conditions like Duchenne muscular dystrophy. But Woodcock’s most lasting impact at the FDA is her transformation of the way the agency approaches cancer drug approvals.

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  • I headed the Biometric Research Program at the National Cancer Institute for many years and had the opportunity to see a few clinical scientists who had a big impact on the development of effective new drugs for patients with cancer. Dr. Janet Woodcock is one of those individuals. The successes of cancer drug development since about 2005 has been the envy of translational scientists in most other areas of medicine. Unfortunately, most do not understand why we have so many effective new cancer drugs. The main reason is the discovery that cancer is mostly caused by “somatic” (non-inherited) mutations that disrupt the normal organ homeostasis and permit growths to become tumors. The new drugs have been developed to inhibit the de-regulating effect of the mutation. These mutations serve as biomarkers for the selection of patients for clinical trials. This discovery made cancer drug development and evaluation more complex but also more rational and scientifically based rather than just developing DNA toxins in un-selected groups of patients. Dr. Woodcock, with her FDA colleague Dr. Richard Pazdur led the transition to this new paradigm. They provided leadership to the academic community and pharmaceutical industry in this new approach to candidate development and evaluation. Individuals who say that the increase in productivity of cancer drug development is at the expense of approval of numerous poor drugs are incorrect and misleading. Individuals who fault the approval of drugs which have dramatic effects on tumor control although they in themselves may not prolong survival have a simple minded understanding of cancer biology.

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