Regeneron Says FDA to Review Libtayo/Chemotherapy Combo in First-Line NSCLC Treatment
19 Januar 2022 - 1:52PM
Dow Jones News
By Colin Kellaher
Regeneron Pharmaceuticals Inc. on Wednesday said the U.S. Food
and Drug Administration accepted for review its application for
expanded use of the cancer drug Libtayo, in combination with
chemotherapy, as first-line treatment in advanced non-small cell
lung cancer.
The Tarrytown, N.Y., biotechnology company, which is developing
and commercializing Libtayo with France's Sanofi SA under a global
collaboration agreement, said the agency set a target action date
of Sept. 19.
The companies also recently filed for European regulatory
approval in the indication.
Regeneron said the application is supported by results from a
randomized, multicenter Phase 3 study that was stopped early after
the combination showed a significant overall survival improvement
compared to chemotherapy alone.
Non-small cell lung cancer accounts for roughly 84% of all lung
cancer, the leading cause of cancer death worldwide, Regeneron
said.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 19, 2022 07:37 ET (12:37 GMT)
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