Merck announced the withdrawal of the U.S. indication for Keytruda for the treatment of patients with metastatic small cell lung cancer

Merck announced the company is voluntarily withdrawing the U.S. indication for Keytruda (pembrolizumab) for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

The withdrawal of this indication was done in consultation with the FDA, and Merck is working to complete this process over the coming weeks. This decision does not affect other indications for Keytruda, Merck’s anti-PD-1 therapy. This accelerated approval for Keytruda was granted in June 2019 based on tumor response rate and durability of response data from KEYNOTE-158 (cohort G) and KEYNOTE-028 (cohort C1). Continued approval for this indication was contingent upon completion of the post-marketing requirement establishing superiority of Keytruda as determined by overall survival (OS).

As announced in January 2020, KEYNOTE-604, the confirmatory Phase III trial for this indication, met one of its dual primary endpoints of progression-free survival but did not reach statistical significance for the other primary endpoint of OS.

Merck’s consultation with the FDA on this withdrawal is part of an industry-wide evaluation of indications based on accelerated approvals that have not yet met their post-marketing requirements.