logo
  

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
Ryanair Holdings Plc reported Monday a loss in its fiscal year 2022, narrower than last year, with strong growth in traffic and load factor. Looking ahead, the company said it expects to return to reasonable profitability in fiscal 2023. Shares of the low fares airline were losing around 4 percent in the morning trading in Germany. The U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS has issued a public health alert against Weis Markets' ready-to-eat or RTE General Tso Chicken meals due to misbranding and undeclared milk, a known allergen. The RTE General Tso Chicken meals were prepared, labeled and sold in the Deli area at Weis Markets stores between April 13 and May 11, 2022. Deutsche Telekom AG on Friday raised its fiscal 2022 adjusted earnings forecast after reporting significantly higher net profit in its first quarter. Shares of the German telecom major were gaining around 1 percent in the morning trading in Germany. For fiscal 2022, the company now expects to post adjusted EBITDA AL of more than 36.6 billion euros.
Follow RTT