REGN : FDA Accepts For Review Libtayo-Chemotherapy Combination For Advanced Lung Cancer Treatment

Regeneron Pharmaceuticals Inc. (REGN) said Wednesday that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer or NSCLC.

The target action date for the FDA decision is September 19, 2022.

In 2021, Libtayo was approved in the U.S. and European Union as first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score =50%), as determined by an FDA-approved test.

Libtayo, which was invented using Regeneron's proprietary VelocImmune technology, is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Asweets Global Inc. is recalling about 2,000 units of Wonder & Wise Activity Tables for potential risk of choking hazard to young children, a statement by the U.S. Consumer Product Safety Commission (CPSC) showed. The company said the screws of the tables can become loose and/or detach from the xylophone component of the activity tables to pose a choking hazard to young children. Chinese e-commerce giant Alibaba Group Holdings Ltd. (BABA) reported Thursday a net loss for the fourth quarter that sharply widened from last year, despite 9 percent growth in revenues, hurt by a decreases in the market prices of our equity investments in publicly-traded companies. Omni-channel fashion retailer Macy's, Inc. (M) reported Thursday a first-quarter net income of $286 million or $0.98 per share, sharply higher than $103 million or $0.32 per share in the prior-year quarter. Excluding items, adjusted net income for the quarter was $315 million or $1.08 per share, compared...
Follow RTT