Regulatory approval

Published by the European Medicines Agency.

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.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
EMA (1) EGFR Exon 20 (Insertion) Non-Small Cell Lung Cancer Amivantamab, Carboplatin, Pemetrexed