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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

Guidelines for Ancient DNA Work

More than two dozen researchers have developed new ethical guidelines for conducting ancient DNA research, which they present in Nature.

And Cleared

A UK regulator has cleared former UK Prime Minister David Cameron in concerns he should have registered as a consultant-lobbyist for his work with Illumina, according to the Financial Times.

Suit Over Allegations

The Boston Globe reports that David Sabatini, who was placed on leave from MIT after allegations of sexual harassment, is suing his accuser, the Whitehead Institute, and the institute's director.

Nature Papers on Esophageal Cancer, Origin of Modern Horses, Exome Sequencing of UK Biobank Participants

In Nature this week: genetic and environmental influences of esophageal cancer, domestic horse origin traced to Western Eurasian steppes, and more.