Regeneron, Sanofi Gets FDA OK of Libtayo in Advanced Non-Small Cell Lung Cancer

By Colin Kellaher

Regeneron Pharmaceuticals Inc. and Sanofi SA on Monday said the U.S. Food and Drug Administration approved the expanded use of their anti-PD-1 cancer drug Libtayo to include the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have with programmed death-ligand 1, or PD-L1, expression of at least 50%.

The companies said patients must either have metastatic or locally advanced tumors that aren't candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

The approval is the third in the U.S. for Libtayo and comes on the heels of the FDA's nod earlier this month as the first immunotherapy indicated for patients with advanced basal cell carcinoma.

Regeneron, of Tarrytown, N.Y., and France's Sanofi are jointly developing and commercializing Libtayo under a global collaboration agreement.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

February 22, 2021 13:30 ET (18:30 GMT)

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