Libtayo filed with FDA and MAA for metastatic non-small cell lung cancer with minimum 50% PD-L1.- Regeneron/Sanofi

Regeneron Pharmaceuticals announced that the FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with at least 50% PD-L1 expression. The target action date for the FDA decision is February 28, 2021. The sBLA is supported by results from a Phase III open-label, randomized, multi-center trial that investigated the first-line treatment of Libtayo monotherapy compared to platinum-doublet chemotherapy in patients with locally advanced or metastatic NSCLC whose tumor cells expressed PD-L1, including those whose cancers had confirmed PD-L1 expression of at least 50% using the PD-L1 IHC 22C3 pharmDx kit. Results were recently presented at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress in September.The European Medicines Agency (EMA) is also assessing Libtayo in advanced NSCLC with at least 50% PD-L1 expression and a decision is expected in the second quarter of 2021. Libtayo is the first systemic treatment approved in the U.S. and European Union (EU) for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.