Regeneron Pharmaceuticals Inc. (REGN) announced that the U.S. Food and Drug Administration has accepted for priority review the supplemental Biologics License Application or sBLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc).
The sBLA is to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with =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 3 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.
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. It is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement.
Results were recently presented at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress in September.
The company noted that the European Medicines Agency or EMA is also assessing Libtayo in advanced NSCLC with =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 for adults with metastatic cutaneous squamous cell carcinoma or CSCC, or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
The company noted that the use of Libtayo to treat advanced NSCLC is investigational and has not been fully evaluated by any regulatory authority.
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