Sanofi’s and Regeneron’s Libtayo Wins FDA Approval for NSCLC

The FDA has approved Sanofi’s and Regeneron Pharmaceuticals’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) for the first-line treatment of nonsmall-cell lung cancer (NSCLC) with high PD-L1 expression.

The drug is now cleared in the U.S. to treat patients with advanced NSCLC whose tumors show high PD-L1 expression as determined by an FDA-approved test. Patients must have either metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

The approval is the third for the drug and follows FDA priority review. Libtayo was also approved this month as the first immunotherapy for patients with advanced basal-cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for patients that are not eligible for an HHI.