Regeneron, Sanofi Gets FDA OK of Libtayo in Advanced Non-Small Cell Lung Cancer
February 22 2021 - 1:45PM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 22, 2021 13:30 ET (18:30 GMT)
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