FDA accepts for priority review supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) for advanced non-small cell lung cancer with PD-L1 expression of ≥50%

The sBLA for this monoclonal antibody targeting immune checkpoint receptor PD-1 on T-cells is supported by results from RCT of 1st line treatment of Libtayo monotherapy vs. platinum-doublet chemotherapy. Decision from the European Medicines Agency expected second quarter of 2021.

Source:

Biospace Inc.