EC approves nivolumab for squamous NSCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said the European Commission approved an MAA for nivolumab to treat locally advanced or metastatic squamous non-small cell lung cancer after prior chemotherapy. Last month, the EC approved the human IgG4 mAb against PD-1 to treat adults with advanced melanoma (see BioCentury Extra, June 19).

FDA approved nivolumab, known in the U.S. as Opdivo, in March to treat metastatic squamous NSCLC with progression on or after platinum-based chemotherapy. It was already approved in the U.S. to treat unresectable or metastatic melanoma and disease progression following treatment with BMS's Yervoy ipilimumab, and if the patient is BRAF V600 mutation-positive, Yervoy plus a BRAF inhibitor (see BioCentury Extra, March 4). ...