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/2024/761210s003lbl.pdf. Revised March 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 first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.	1
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	EGFR Exon 20 (Insertion)	Non-Small Cell Lung Cancer	Amivantamab, Carboplatin, Pemetrexed
FDA (1)	EGFR Exon 20 (Insertion)	Non-Small Cell Lung Cancer	Amivantamab