Regeneron Says FDA to Review Libtayo/Chemotherapy Combo in First-Line NSCLC Treatment

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 [e-mail]

(END) Dow Jones Newswires

01-19-22 0737ET