Regeneron Pharmaceuticals Inc. (REGN) said Wednesday that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer or NSCLC.
The target action date for the FDA decision is September 19, 2022.
In 2021, Libtayo was approved in the U.S. and European Union as first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score =50%), as determined by an FDA-approved test.
Libtayo, which was invented using Regeneron's proprietary VelocImmune technology, is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
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