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.