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.