News
FDA approves Libtayo to treat non small cell lung cancer.-Regeneron + Sanofi
The FDA has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) from Regeneron + Sanofi, 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 greater than 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.
The data supporting the Libtayo approval are based on an analysis of 710 patients who were randomized to receive treatment in a Phase III trial; eligible patients were intended to have PD-L1 expression of greater than 50%. In this patient population, Libtayo reduced the risk of death by 32% compared to chemotherapy.
Condition: Non Small Cell Lung Cancer
Type: drug
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