Rybrevant (amivantamab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Janssen-Cilag International N.V. Rybrevant (amivantamab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf. Revised July 2024. Accessed August 25, 2024.

Regulatory approvals

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

Indication	Statements
Rybrevant is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations.	1
Rybrevant is indicated as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based chemotherapy.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR Exon 20 (Insertion)	Non-Small Cell Lung Cancer	Amivantamab, Carboplatin, Pemetrexed
Sensitivity (+)	EGFR Exon 20 (Insertion)	Non-Small Cell Lung Cancer	Amivantamab