Regulatory approval

Published by the European Medicines Agency. Approved

Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.

This is written in the approval document.

Citation

Roche Registration GmbH. Tarceva (erlotinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf. Revised May 2023. Accessed March 23, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	EGFR activating variants	Non-Small Cell Lung Cancer	Erlotinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2011-08-24	European Medicines Agency	Indication received approval from the European Commission.