Latecomer Libtayo Wins Coveted First-Line NSCLC Monotherapy Indication

Sanofi/Regeneron's PD-1 inhibitor Libtayo joins Keytruda and Tecentriq as the only PD-1/L1s approved by the US FDA as monotherapy for first-line non-small cell lung cancer.

Blue targets and three arrows reaching the center of the first one — Libtayo joins a competitive field with a new lung cancer indication • Source: Shutterstock (Shutterstock)

Sanofi and Regeneron Pharmaceuticals, Inc. were late to market with their PD-1 inhibitor Libtayo (cemiplimab-rwlc), but they have won a coveted approval from the US Food and Drug Administration for the first-line treatment of advanced non-small cell lung cancer (NSCLC) as a monotherapy, joining only Merck & Co., Inc.'s Keytruda (pembrolizumab) and Roche Holding AG's Tecentriq (atezolizumab) with that specific indication.

The commercial opportunity is considered a significant one in the field of cancer, but Merck's Keytruda has emerged as the...