Benzinga | Feb 10, 2021 05:24AM EST

Sanofi/Regeneron's Libtayo Wins FDA Approval For A Type Of Skin Cancer

* Sanofi SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) immunotherapy Libtayo (cemiplimab-rwlc) has scored approval from the FDA for the treatment of advanced basal cell carcinoma (BCC), the most common type of skin cancer in the U.S.

* The FDA has indicated Libtayo for treating previously-treated, advanced BCC patients who have already received a hedgehog pathway inhibitor (HHI) or who cannot be treated with an HHI.

* The PD-1 inhibitor has been granted full approval for patients with locally advanced BCC and accelerated approval for patients with metastatic BCC, which has spread to other parts of the body.

* In 2018, Libtayo was approved as the first systemic treatment for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

* Price Action: REGN closed 0.8% down at $490.68, while, SNY closed 0.5% higher at $48.86.