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

NEW YORK – 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.

The agency based its decision to approve amivantamab on the results of the Phase I CHRYSALIS trial, in which 81 NSCLC patients harboring EGFR exon 20 insertion mutations, all of whom had disease progression after platinum-based chemotherapy, received amivantamab. The overall response rate among patients treated with amivantamab was 40 percent and the median duration of response was 11.1 months. Sixty-three percent of patients responded to the treatment for more than six months.

Patients with EGFR exon 20 mutations — who comprise around 2 or 3 percent of NSCLCs — typically experience poorer outcomes, and the FDA's amivantamab approval marks the first targeted treatment specifically indicated for patients with these mutations.