Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized amivantamab 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.

This is written in the approval document as:

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.

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 2025. Accessed September 5, 2025.

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2025-04-04	European Medicines Agency	Indication received approval from the European Commission.
2024-10-20	Van Allen lab	Adding EMA approvals for use to database