medwireNews: The EMA’s Committee for Medicinal Products for Human Use has granted a positive opinion for conditional marketing authorization for amivantamab in non-small-cell lung cancer (NSCLC) patients with an activating EGFR exon 20 insertion mutation after the failure of platinum-based chemotherapy.
The immunoglobulin G1-based EGFR–MET bispecific antibody has also been approved for this NSCLC indication by the US FDA following positive phase 1 CHRYSALIS trial results for objective response rate and duration.
The agent is associated with adverse events including rash, infusion-related reactions, nail toxicity, hypoalbuminemia, edema, fatigue, stomatitis, nausea, and constipation.
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