FDA accepts sBLA for Keytruda to treat advanced small cell lung cancer. - Merck Inc.,
Merck Inc., announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) Merck�s anti-PD-1 therapy, as monotherapy for the treatment of patients with advanced small cell lung cancer (SCLC) whose disease has progressed after two or more lines of prior therapy. This sBLA, which is seeking accelerated approval for this new indication, is based on data from the SCLC cohorts of the Phase II KEYNOTE-158 and Phase 1b KEYNOTE-028 trials.
The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of 17 June 2019.
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