FDA approves cemiplimab-rwlc from Sanofi, Regeneron

FDA approved Libtayo cemiplimab-rwlc from partners Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in patients who are not candidates for curative surgery or curative radiation. FDA said the human mAb against PD-1 is the first drug approved for advanced CSCC. The approval came one month ahead of its Oct. 28 PDUFA date.

The partners have launched Libtayo at a wholesale acquisition cost (WAC) of $9,100 per three-week treatment cycle. According to its label, the drug is to be administered every three weeks until disease progression or unacceptable toxicity...