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/2024/761210s004lbl.pdf. Revised September 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 carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.	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, Carboplatin, Pemetrexed
FDA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Amivantamab, Carboplatin, Pemetrexed