FDA approves Libtayo as first immunotherapy indicated for patients with advanced basal cell carcinoma – Sanofi

The FDA has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) from Sanofi as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate.

Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC.

Libtayo is the first treatment to show a clinical benefit in patients with advanced BCC after HHI therapy in a pivotal trial. The full approval in locally advanced BCC is based on the primary analysis from the trial, and the accelerated approval in metastatic BCC is based on an interim analysis showing the impact of Libtayo on tumor response rate and durability of response. Continued approval may be contingent on additional data from the trial verifying clinical benefit.