On­col­o­gists lis­ten when the FDA speaks, even af­ter a drug hits the mar­ket

The FDA took off some of the guard rails in an ef­fort to speed in­no­va­tion. The ques­tion was if, once those were gone, there’d be some­one to pull the emer­gency stop when things went wrong.

A new study in JA­MA on on­col­o­gists and two im­munother­a­pies the FDA re­strict­ed af­ter ap­proval sug­gests the sec­ondary brakes do work. Re­searchers at the Uni­ver­si­ty of Penn­syl­va­nia tracked us­age rates for two blad­der can­cer im­munother­a­pies the FDA ap­proved in 2017 but re­strict­ed in 2018 af­ter da­ta showed that sur­vival rates were worse in the new ther­a­pies than in the stan­dard cis­platin-based chemother­a­py. They found that on­col­o­gists de­creased their us­age of the im­munother­a­py by over 20 per­cent­age points and in­creased their us­age of chemother­a­py by over 20 per­cent­age points, sug­gest­ing that doc­tors were close­ly mon­i­tor­ing FDA up­dates and ad­just­ing their treat­ments ac­cord­ing­ly.

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