Libtayo + chemotherapy has a CHMP recommendation for the treatment of advanced PD-L1 positive non small cell cancer.- Regeneron
Regeneron Pharmaceuticals, Inc. announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo (cemiplimab) in combination with platinum-based chemotherapy.
Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with greater than 1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.
The European Commission is expected to make a final decision on the application in the coming months. In November 2022, the Libtayo combination was approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression.
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