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FDA accepts for review a new sBLA for Keytruda in NSCLC

The US Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License (sBLA) for Merck’s Keytruda (pembrolizumab) to include data from KEYNOTE-010. KEYNOTE-010 was a pivotal Phase 2/3 study designed to evaluate Keytruda compared to chemotherapy based on prospective measurement of PD-L1 expression in previously treated patients with advanced non-small cell lung cancer (NSCLC).

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