Rybrevant (amivantamab-vmjw) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Janssen Biotech, Inc. Rybrevant (amivantamab-vmjw) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s005lbl.pdf. Revised August 2024. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
RYBREVANT is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib
FDA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib