Libtayo Granted Priority Review by FDA for Non–small Cell Lung Cancer

The FDA granted priority review to a supplemental biologics license application for cemiplimab-rwlc for the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer.

The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for cemiplimab-rwlc (Libtayo) for the frontline treatment of patients with locally advanced or metastatic non—small cell lung cancer (NSCLC) with a PD-L1 expression of 50% or greater.1 The application is based on data from a phase 3 trial that compared the use of single-agent cemiplimab with platinum-doublet chemotherapy in patients with locally advanced or metastatic disease whose tumors expressed PD-L1, including those with expression of 50% or greater.

Results presented during the 2020 ESMO Virtual Congress showed that cemiplimab resulted in a 43% reduction in the risk of death in the subset of patients with high PD-L1 expression (HR, 0.57; 95% CI, 0.42-0.77; P =.0002).2 In the overall trial population, the PD-1 inhibitor reduced the risk of death by 32% (HR, 0.68; 95% CI, 0.53-0.87; P =.0022). Under the Prescription Drug User Fee Act, the FDA must make a decision on the sBLA by February 28, 2021.

“In…analyses presented at ESMO, [cemiplimab] reduced the risk of death by 43% in patients whose cancer had confirmed PD-L1 expression of 50% or greater. This is notable given that nearly three-quarters of patients crossed over from chemotherapy following disease progression and 12% of patients had pretreated and stable brain metastases,” Ahmet Sezer, MD, associate professor in the Department of Medical Oncology at Baskent University and trial investigator, stated in a press release.2 “These results support [cemiplimab] as a potential new option for anti—PD-L1 monotherapy in first-line advanced NSCLC.”

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