FDA Expands Approval of Libtayo for NSCLC

The FDA has expanded its approval of Regeneron’s Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for first-line treatment of adult patients with advanced nonsmall-cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations that is either locally advanced — where patients are not candidates for surgical resection or definitive chemoradiation — or metastatic.

A PD-1 blocking antibody for intravenous use, Libtayo is also FDA-approved as a single agent for the first-line treatment of such NSCLC patients.

The expanded approval was based on efficacy in a study in which Libtayo plus platinum-based chemotherapy improved overall survival compared to placebo plus chemotherapy.

Libtayo first received FDA approval in 2018.