Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized amivantamab as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations, after failure of platinum-based chemotherapy.

This is written in the approval document as:

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.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-12-09	European Medicines Agency	Indication received approval from the European Commission.