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# Regeneron sBLA for Libtayo in Lung Cancer
- URL: https://www.fdaweb.com/regeneron-sbla-for-libtayo-in-lung-cancer/
- Published: 2022-01-19T12:00:00.000Z
- Updated: 2026-09-14T17:29:06.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150955

FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as a first-line treatment in advanced non-small cell lung cancer (NSCLC). The user fee review action target date is 9/19\. Libtayo was approved last year as a first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression.

The submission is based on data from a 466-patient randomized, multicenter Phase 3 trial that assessed Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone. The trial was stopped early after the Libtayo combination demonstrated a significant overall survival improvement compared to chemotherapy alone, according to Regeneron.

On the safety side, the company says patients in the Libtayo combination (n=312) and chemotherapy alone (n=154) groups saw treatment discontinuations due to adverse events in 5% and 3% of patients, respectively. Immune-mediated adverse events occurred in 19% of patients in the Libtayo combination group.