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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.

The Scan

Another Resignation

According to the Wall Street Journal, a third advisory panel member has resigned following the US Food and Drug Administration's approval of an Alzheimer's disease drug.

Novavax Finds Its Vaccine Effective

Reuters reports Novavax's SARS-CoV-2 vaccine is more than 90 percent effective in preventing COVID-19.

Can't Be Used

The US Food and Drug Administration says millions of vaccine doses made at an embattled manufacturing facility cannot be used, the New York Times reports.

PLOS Papers on Frozen Shoulder GWAS, Epstein-Barr Effects on Immune Cell Epigenetics, More

In PLOS this week: genome-wide association study of frozen shoulder, epigenetic patterns of Epstein-Barr-infected B lymphocyte cells, and more.