FDA Approvals, News & UpdatesLung Cancer

Libtayo Approved for First-Line Treatment of Advanced Lung Cancer

The immunotherapy Libtayo received FDA approval as first-line treatment for patients with advanced or metastatic non–small-cell lung cancer and high PD-L1 expression.
April 2021 Vol 7 No 2

In February 2021, the FDA approved a new indication for Libtayo (cemiplimab; from Regeneron/sanofi-aventis), a PD-1 inhibitor, for the first-line treatment of patients with advanced or metastatic (spreading) non–small-cell lung cancer (NSCLC) who are not candidates for surgery or curative chemoradiation and whose tumors have high PD-L1 expression but no EGFR, ALK, or ROS1 mutations.

Libtayo was previously approved for the treatment of skin cancer.

This new approval was based on data from Study 1624 that included 710 patients with advanced or metastatic NSCLC who were not candidates for surgery or chemoradiation. The patients were divided into 2 groups to receive either intravenous Libtayo every 3 weeks for 108 weeks or platinum-based chemotherapy.

The average overall survival was 22.1 months with Libtayo versus 14.3 months with chemotherapy. The average time without disease progression was 6.2 months with Libtayo versus 5.6 months with chemotherapy. The overall response rate was 37% with Libtayo and 21% with chemotherapy.

The most common side effects with Libtayo in this study were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.

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Last modified: June 8, 2021

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