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ARTICLE | Clinical News

Keytruda under Priority Review for first-line squamous NSCLC

July 13, 2018 6:57 PM UTC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab plus carboplatin/paclitaxel or Abraxane nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer regardless of PD-L1 expression. The PDUFA date is Oct. 30.

Merck's submission is based on data from the Phase III KEYNOTE-407 trial in which Keytruda plus chemotherapy met the primary endpoints of improving progression-free survival (PFS) and overall survival (OS) vs. chemotherapy alone (see "Phase III Squamous NSCLC Survival Readouts at ASCO for Keytruda, Tecentriq")...