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25-05-2021 | FDA | News

approvalsWatch

FDA approves amivantamab for advanced NSCLC with EGFR exon 20 insertions

Author: Hannah Kitt

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medwireNews: Amivantamab-vmjw has been granted accelerated approval by the US FDA for use in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations after prior platinum-based chemotherapy.

The FDA also approved the Guardant360® CDx assay (Guardant Health Inc, Redwood City, California, USA) as a companion diagnostic test to detect the insertions.

The decision is based on results of the phase 1 CHRYSALIS trial, which showed an overall response rate of 40% and a median duration of response of 11.1 months with the EGFR- and MET-targeted bispecific antibody in this patient population.

The recommended amivantamab dose for patients with a bodyweight below 80 kg at treatment initiation is 1050 mg once a week for 4 weeks then once every 2 weeks, and is 1400 mg on the same schedule for patients who weigh 80 kg or more.

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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