FDA approves Libtayo as first immunotherapy for advanced BCC

The US Food and Drug Administration has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) 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, two of the most common skin cancers in the USA.

Libtayo is being jointly developed by French pharma major Sanofi (Euronext: SAN) and US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) under a global collaboration agreement.