FDA Approves Amivantamab-vmjw for EGFR Exon 20-Mutant NSCLC


This is the first targeted therapy regimen approved for this patient population.

The FDA approved amivantamab-vmjw (Rybrevant) for the treatment of adults with non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 20 insertion mutations. This is the first targeted therapy approved for this subset of lung cancers.

The agency also approved a companion diagnostic — Guardant360 CDx.

“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, 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, in a statement.

The approval was based on findings from a clinical trial that included 81 patients with NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after receiving platinum-based chemotherapy. The overall response rate in patients who received amivantamab-vmjw was 40%, and average duration of response was 11.1 months. Sixty-three percent of patients had a response that lasted 6 months or longer.

Common adverse events of the targeted agent include: rash, skin infections around the finger and toenails, infusion-related reactions, muscle and joint pain, nausea, fatigue, shortness of breath, swelling in the lower legs or hand or face, mouth sores, constipation, cough, vomiting, and changes in some blood tests.

If patients start to show symptoms of interstitial lung disease, treatment with amivantamab-vmjw should be stopped; if interstitial lung disease is confirmed, treatment with the drug should be discontinued permanently.

Nurses should also talk to patients about sun exposure, which should be limited for 2 months after treatment with amivantamab-vmjw, as well as the possibility of vision problems occurring. Before prescribing the drug, clinicians should be sure that women are not pregnant.

“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,” Beaver said.


FDA. FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer. May 21, 2021. https://content.govdelivery.com/accounts/USFDA/bulletins/2da97ee

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