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FDA approves Keytruda as first-line NSCLC therapy

October 24, 2016 7:00 AM UTC

Merck & Co. Inc. (NYSE:MRK) said late Monday FDA approved Keytruda pembrolizumab as a first-line treatment for metastatic non-small lung cancer patients with ≥50% PD-L1 expression and with no EGFR or anaplastic lymphoma kinase (ALK) tumor aberrations. The approval is the first for a mAb against PD-1 in first-line metastatic NSCLC.

FDA based the first-line approval on data from the Phase III KEYNOTE-024 trial (see BioCentury Extra, June 16). ...