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Regulatory Focus™ > News Articles > 2021 > 2 > FDA Approvals Roundup: Libtayo

FDA Approvals Roundup: Libtayo

Posted 24 February 2021 | By Renee Matthews 

FDA Approvals Roundup: Libtayo

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New indications
Libtayo gets extended indication for NSCLC with high PD-L1 expression
Regeneron’s Libtayo (cemiplimab-rwlc injection) has been approved as a first-line therapy for advanced non‒small cell lung cancer (NSCLC) in patients whose tumors have high programmed death-ligand 1 expression established by an FDA-approved test. The patients must have either metastatic or locally advanced tumors that are not candidates for surgical resection or chemoradiation, and the tumors must not have EGFR, ALK, or ROS1 aberrations.*
The approval was based on efficacy findings from a multicenter, randomized, open-label study in 710 patients from the indicated population who were randomized (1:1) to receive intravenous Libtayo or a platinum-based chemotherapy. Patients receiving the study drug showed statistically significant improvements in overall survival compared with those in the chemotherapy arm (22.1 vs. 14.3 months, respectively; P = .0022) and in progression-free survival (6.2 vs. 5.6 months; P < .0001). Overall response rates were 37% versus 21%, respectively.
The application for this indication was granted priority review. This review used the assessment aid.
Libtayo was first approved in 2018 and is used to treat cutaneous squamous cell carcinoma and basal cell carcinoma.

*Updated to reflect correct indication.


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Tags: FDA, US

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