Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that EGFR Exon 20 (Insertion) status confers therapeutic sensitivity to Amivantamab in patients with Non-Small Cell Lung Cancer.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.