Merck & Co Inc has voluntarily withdrawn the metastatic small cell lung cancer indication for Keytruda (pembrolizumab) following the results of a Phase 3 study which didn’t support the terms of its earlier accelerated approval from the US Food and Drug Administration. The FDA awards accelerated approvals to certain drugs, based on surrogate endpoints, but confirmation of clinical benefit needs to be verified in subsequent trials.
The decision doesn’t affect other indications for Keytruda, the company said.