FDA approves Keytruda for first-line squamous NSCLC

Merck & Co. Inc. (NYSE:MRK) said FDA approved Keytruda pembrolizumab plus carboplatin/paclitaxel or Abraxane nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression. The sBLA was under Priority Review.

Merck's submission was 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")...