A supplemental biologics license application seeking the expanded approval of amivantamab-vmjw in combination with carboplatin plus pemetrexed for use in the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations has been submitted to the FDA.
Amivantamab elicited an objective response rate of 37% per investigator assessment, with a median duration of response of 12.5 months, according to long-term data from the CHRYSALIS trial.
Amivantamab continued to be tolerable and efficacious in patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease progressed on platinum-based chemotherapy.
For EU Trade and Medical Media Only. Not to Be Distributed to UK and Benelux Based Media Conditional Marketing Authorisation is based on results from the Phase 1 CHRYSALIS study evaluating amivantamab
If approved by the European Commission, amivantamab will be the first treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for advanced non-small cell lung cancer