FDA’s Pazdur on accelerated approval, single-arm studies, and his future

CHICAGO — When most cancers medication granted accelerated approval within the U.S. later prove to not profit sufferers, the Meals and Drug Administration would favor drugmakers take away them from the market voluntarily. However only a few firms are keen to do this, which generally forces Richard Pazdur, the company’s prime most cancers drug regulator, to select up the cellphone and have a blunt dialog with drug firm executives.

“Peggy Hamburg, a former FDA commissioner, gave me a phrase that I usually use — in case you don’t see the sunshine, you’ll quickly really feel the warmth,” Pazdur mentioned Friday night, talking at a STAT occasion through the annual assembly of the American Society of Medical Oncology.