Oncologists Listen When the FDA Speaks, Even After a Drug Hits the Market

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.

The therapies were approved through the FDA’s controversial accelerated approval program, based on single-arm Phase II clinical trials as opposed to the full gold-standard Phase III randomized studies. The FDA subsequently restricted the program to patients not eligible for chemo.

“Oncology physicians responded very quickly to an FDA warning and label change for two very popular drugs,” lead author Ravi Parikh told Endpoints News.  “What this means is that this is a viable strategy to respond to safety concerns for drugs obtaining accelerated approval in the future. “