Regeneron Pharmaceuticals, Inc. (REGN), and French drug maker Sanofi, said Friday that they voluntarily withdrew the supplemental Biologics License Application or sBLA, filed for Libtayo or Cemiplimab-rwlc, as a second-line treatment for advanced cervical cancer.
The move follows after the both parties and the U.S. Food and Drug Administration (FDA) were not able to align on certain post-marketing studies. However, the discussions on the drug are continuing with regulatory authorities outside of the U.S.
"Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation," the companies said in a joint statement. Libtayo is currently prescribed for certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell lung cancer (NSCLC).
The drug is also currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers.
However, the companies added that these potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
Libtayo was invented using Regeneron's proprietary VelocImmune technology, is being jointly developed by Regeneron and Sanofi under a global collaboration.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.