STAT+: The FDA’s Pazdur on accelerated approval, single-arm studies, and his own future

Richard Pazdur, the FDA's top cancer drug regulator, acknowledged that the accelerated approval of cancer drugs is “under attack,” but he deflected blame away from the agency.

CHICAGO — When cancer drugs granted accelerated approval in the U.S. later turn out not to benefit patients, the Food and Drug Administration would prefer drugmakers remove them from the market voluntarily. But very few companies are willing to do that, which sometimes forces Richard Pazdur, the agency’s top cancer drug regulator, to pick up the phone and have a blunt conversation with drug company executives.

“Peggy Hamburg, a former FDA commissioner, gave me a phrase that I often use — if you don’t see the light, you will soon feel the heat,” Pazdur said Friday evening, speaking at a STAT event during the annual meeting of the American Society of Clinical Oncology.

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