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14-03-2023 | EMA | News


EMA recommends extension to cemiplimab indication

Author: Shreeya Nanda


medwireNews: The EMA’s Committee for Medicinal Products for Human Use has endorsed the adoption of a new indication for cemiplimab, to treat patients with PD-L1-positive, advanced non-small-cell lung cancer (NSCLC) in combination with platinum-based chemotherapy.

Specifically, the cemiplimab–chemotherapy combination is indicated for adults with a tumoral PD-L1 expression level of at least 1% who do not harbor EGFR, ALK, or ROS1 alterations and who have locally advanced NSCLC not suitable for definitive chemoradiation or metastatic disease.

The regulatory agency previously supported the use of the PD-1 inhibitor as monotherapy for the first-line treatment of patients with PD-L1 expression levels of at least 50%, and the agent is also approved for the treatment of basal cell carcinoma and cervical cancer.

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