FDA accepts Libtayo for priority review in first-line advanced NSCLC

The US Food and Drug Administration 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 ≥50% PD-L1 expression.

The target action date for the FDA decision is February 28, 2021, said the drug’s developer Regeneron Pharmaceutical (Nasdaq: REGN), whose shares closed up nearly 1% at $548.58, despite the negative news of a pause on a trial of its COVID-19 antibody cocktail REGN-COV2 also released yesterday.

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 ≥50% using the PD-L1 IHC 22C3 pharmDx kit. Results were presented at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress in September.