FDA Approves Libtayo® as Monotherapy for Advanced NSCLC
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Subject: FDA Approves Libtayo
Regeneron and Sanofi received U.S. FDA approval for Libtayo® (cemiplimab-rwlc, an PD-1 inhibitor) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), %), as determined by an FDA-approved test. Patients must either have 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.
This NSCLC indication is the third FDA approval for LIBTAYO and follows another approval earlier this month for patients with advanced basal cell carcinoma previously treated with a hedgehog inhibitor (HHI) or for whom a HHI is not appropriate.