Regeneron, Sanofi Pull FDA Application for Libtayo

Regeneron Pharmaceuticals and Sanofi said they are voluntarily withdrawing their supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.

Regeneron Pharmaceuticals and Sanofi said they are voluntarily withdrawing their supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.

The two companies and the Food and Drug Administration (FDA) “were not able to align on certain post-marketing studies,” Regeneron and Sanofi said in a news release.

However, the companies are continuing discussions on approval with regulatory authorities outside of the U.S.

In addition, Libtayo is approved by the FDA to treat other types of cancers and realized sales of $78 million in the U.S. in the third quarter of 2021.

The human monoclonal antibody which targets the immune checkpoint receptor PD-1 on T-cells, is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell lung cancer (NSCLC).

Libtayo is 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.