medwireNews: Cemiplimab-rwlc plus chemotherapy can be used as a first-line treatment option for US patients with advanced non-small-cell lung cancer (NSCLC), following a positive decision by the FDA.
The PD-1 inhibitor in combination with platinum-based chemotherapy is indicated for adults lacking EGFR, ALK, or ROS1 alterations who have not received prior systemic therapy for advanced disease.
The decision is based on the EMPOWER-Lung 3 trial (also known as Study 16113), which showed a significant improvement in the primary endpoint of overall survival as well as the secondary endpoints of progression-free survival and objective response rate with the addition of cemiplimab to first-line chemotherapy in this patient population.
The FDA recommends that cemiplimab be given intravenously at a dose of 350 mg every 3 weeks.
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