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18-10-2021 | Oncology | News | Article

approvalsWatch

Amivantamab receives EMA support for EGFR exon 20-mutated NSCLC

Author:
Lynda Williams

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.

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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