EMA recommends cemiplimab for first-line NSCLC treatment
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.
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