Skip to main content
Premium Trial:

Request an Annual Quote

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

Call for a Different Tack

Experts weigh the value of recent experiments testing genetically modified pig kidneys using brain-dead individuals, according to Nature News.

Wastewater Warning

The New York Times reports that wastewater surveillance in some parts of the US point to a possible surge.

Can't Get in the Program

Due to the Northern Ireland protocol dispute, the European Union is preventing UK researchers from joining the Horizon Europe research program, the Times of London reports.

Science Paper on Spatial-Controlled Genome Editing

In Science this week: approach to enable a CRISPR-Cas13a-based system to be used as a cancer therapy.