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# Regeneron Libtayo sBLA for Cervical Cancer
- URL: https://www.fdaweb.com/regeneron-libtayo-sbla-for-cervical-cancer/
- Published: 2021-09-28T12:00:00.000Z
- Updated: 2026-09-14T17:16:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150240

FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The user fee review action target date is 1/30/2022.

The submission is based on data from the Phase 3 EMPOWER-Cervical 1 clinical trial that evaluated Libtayo monotherapy versus an investigator’s choice of chemotherapy in patients with recurrent or metastatic cervical cancer who had progressed on platinum-based chemotherapy, according to the company. The primary endpoint for the trial was overall survival.

Regeneron describes Libtayo as a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor 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, it says.

Libtayo is currently approved for treating several types of skin cancer. It is also approved for treating non-small cell lung cancer.