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EMA's CHMP Issues Positive Opinion on Regeneron, Sanofi's Libtayo in NSCLC

NEW YORK – Regeneron Pharmaceuticals and Sanofi on Monday said the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has recommended approval for cemiplimab (Libtayo) as a first-line option for patients with PD-L1-positive, advanced non-small cell lung cancer.

CHMP specifically recommended approval for Regeneron and Sanofi's anti-PD-1 treatment for metastatic or locally advanced NSCLC patients who have not received treatment and cannot receive chemoradiation. Patients must have PD-L1 expression in at least 50 percent of tumor cells and cannot harbor EGFR, ALK, or ROS1 alterations.

The committee made its decision upon reviewing data from the Phase III EMPOWER-Lung 1 trial, which were published earlier this year in The Lancet and showed that cemiplimab significantly extended overall survival compared to platinum-doublet chemotherapy. The PD-1 inhibitor reduced the risk of death by 32 percent in all patients and by 43 percent in those with PD-L1 expression of 50 percent or higher. This pivotal trial also demonstrated the drug's benefits in previously treated patients with brain metastases and those who are not candidates for chemoradiation.

The US Food and Drug Administration used this same data to approve the drug, called cemiplimab-rwlc, in this setting in February. The European Commission, which along with cemiplimab's indication PD-L1-positive NSCLC also recommended approval of the drug for locally advanced or metastatic basal cell carcinoma patients who have progressed on or are intolerant to a hedgehog pathway inhibitor, is slated to make its decision on both these applications in the coming months.