Janssen receives FDA green light for Rybrevant

Janssen has obtained the Food and Drug Administration’s blessing for Rybrevant (amivantamab-vmjw).

The medication is the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor exon 20 insertion mutations.

The FDA also approved the Fuardant Health’s Guardant360 CDx as a companion diagnostic for Rybrevant. 

"Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies," said Julia Beaver, chief of medical oncology in the FDA's Oncology Center of Excellence and acting deputy director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. "With today's approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option."