Lilly's NSCLC drug among host of approvals

FDA and EMA each approved multiple drugs early this week, including the first approval for Portrazza necitumumab ( LY3012211) from Eli Lilly and Co.(NYSE:LLY). FDA approved Portrazza in combination with chemotherapy as a first-line treatment for squamous non-small cell lung cancer (NSCLC). Lilly intends to launch and price the human IgG1 mAb against EGFR within weeks.

FDA also approved Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) as a single agent for patients with previously untreated BRAF V600 wild-type advanced melanoma. In October, the agency approved the human IgG4 mAb against PD-1 in combination with BMS's Yervoy ipilimumab for the same indication. FDA has also approved the drug to treat advanced renal cell carcinoma and metastatic squamous non-small cell lung cancer (NSCLC) (see BioCentury Extra, Nov. 23). ...