Merck’s Keytruda wins FDA breakthrough therapy status, priority review for first-line NSCLC
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation and priority review to Merck’s Keytruda (pembrolizumab) for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1.
The agency's action date (PDUFA) is 24 December 2016.
Merck has filed a marketing application in Europe for the similar indication.
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