FDA Approves Janssen’s Rybrevant, Guardant360 CDx for EGFR Exon 20-Mutated NSCLC

The US Food and Drug Administration on Friday granted accelerated approval to Janssen Pharmaceutical’s EGFR-MET bispecific antibody amivantamab (Rybrevant) as a treatment for EGFR exon 20-mutated non-small cell lung cancer, or NSCLC.

The agency also announced it has approved Guardant Health’s Guardant360 CDx, a blood-based next-generation sequencing test designed to detect alterations in 55 genes, as a companion diagnostic to identify patients eligible for amivantamab.

Source: https://www.genomeweb.com/regulatory-news-fda-approvals/fda-approves-janssens-rybrevant-guardant360-cdx-egfr-exon-20-mutated