FDA approves Rybrevant for NSCLC with EGFR exon 20 insertion mutations
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The FDA approved amivantamab-vmjw for treatment of adults with non-small cell lung cancer who harbor EGFR exon 20 insertion mutations.
Amivantamab-vmjw (Rybrevant, Janssen) is an EGFR and mesenchymal epithelial transition (MET) factor bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.
The FDA also approved Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for amivantamab-vmjw.
“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,” Julia Beaver, MD, 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, said in an agency-issued press release. “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.”
NSCLC accounts for 80% to 85% of all lung cancers, according to American Cancer Society. An estimated 2% to 3% of patients with NSCLC have EGFR exon 20 insertion mutations.
The FDA based the approval of amivantamab-vmjw on results of a single-arm study that included 81 patients with NSCLC and EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.
Overall response rate served as the main outcome measure.
Researchers reported a 40% ORR. Median duration of response was 11.1 months, and nearly two-thirds (63%) of responses lasted 6 months or longer.
The most common adverse events reported among patients treated with amivantamab-vmjw included rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting and changes in certain blood tests.
The FDA previously granted priority review and breakthrough therapy designation to amivantamab-vmjw for this indication.
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