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28-05-2021 | EMA | News

approvalsWatch

EMA recommends cemiplimab for first-line NSCLC treatment

Author:
Hannah Kitt

medwireNews: The EMA’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the first-line use of cemiplimab in patients with non-small-cell lung cancer (NSCLC) and high PD-L1 expression.

It is indicated for use specifically in NSCLC patients with metastatic disease or those with locally advanced tumors provided they are unsuitable candidates for definitive chemoradiation; all patients must have PD-L1 expression levels in tumor cells of at least 50% and no EGFR, ALK, or ROS1 alterations.

In March 2021, the US FDA approved use of cemiplimab in this patient population.

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

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