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# Oncologists Respond Swiftly to FDA Safety Alerts: Study
- URL: https://www.fdaweb.com/oncologists-respond-swiftly-to-fda-safety-alerts-study/
- Published: 2019-09-24T12:00:00.000Z
- Updated: 2026-09-15T01:51:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145083

University of Pennsylvania Abramson Cancer Center researchers say that within six months of an FDA move to restrict the labels of two immunotherapies, usage of the drugs among oncologists dropped about 50%. The researchers [say](https://medicalxpress.com/news/2019-09-oncologists-swiftly-fda-safety.html?ref=fdaweb.com) the findings offer reassurance that oncologists “can be nimble enough to quickly incorporate the latest guidelines into their practices when new safety data come to light,” *Medical Express* [reports](https://medicalxpress.com/news/2019-09-oncologists-swiftly-fda-safety.html?ref=fdaweb.com) online.

The post says the FDA accelerated approval program has come under significant scrutiny in recent months, as supporters say it can bring promising drugs to patients more quickly and critics say the drugs should not come to market before undergoing randomized Phase 3 clinical trials.

“We felt it was important to evaluate what the data say about this program, and our findings show oncologists are quick to respond to emerging safety data for drugs approved through this process,” the researchers say.

The study looked at usage rates for the PD-1 inhibitor pembrolizumab and the PD-1 inhibitor atezolizumab. FDA approved both therapies in 2017 based on Phase 2 studies. However, the report says, data from ongoing Phase 3 studies showed patients had decreased survival when taking these drugs compared to undergoing first-line platinum-based chemotherapy. That led the agency to restrict the label indications compared to the original approval, and the restrictions took effect in 6/2018.

The researchers used a de-identified data set derived from health records from more than 280 U.S. oncology clinics.