Regulatory approval

Published by the European Medicines Agency.

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 2024. Accessed August 25, 2024.

Therapeutic response

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

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