Skip to main content
main-content
Top

02-03-2021 | FDA | News

approvalsWatch

FDA approves cemiplimab for high PD-L1-expressing NSCLC

Author:
Lynda Williams

medwireNews: Cemiplimab may be given as a first-line therapy for locally advanced non-small-cell lung cancer (NSCLC) patients who have high PD-L1 expression, the US FDA says.

The approval is based on the findings of the EMPOWER-Lung 1 trial which showed a significant overall survival benefit with the PD-1 inhibitor compared with platinum doublet chemotherapy.

Cemiplimab may be given to patients without metastases who are unsuitable for resection or definitive chemoradiotherapy. Candidates for treatment must also have a PD-L1 tumor proportion score of at least 50% on a FDA-approved test and no evidence of EGFR, ALK, or ROS1 alterations.

The recommended dosage is 350 mg every 3 weeks given over a 30-minute intravenous infusion; adverse reactions highlighted on the label include musculoskeletal pain, rash, anaemia, fatigue, decreased appetite, pneumonia, and cough.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group