Regulatory approval

Published by the Food and Drug Administration. Approved

RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

This is written in the approval document.

Citation

Janssen Biotech, Inc. Rybrevant (amivantamab-vmjw) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s004lbl.pdf. Revised September 2024. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	EGFR Exon 20 (Insertion)	Non-Small Cell Lung Cancer	Amivantamab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-03-01	Food and Drug Administration	Indication received traditional approval.
2021-05-21	Food and Drug Administration	Indication received accelerated approval.