Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized erlotinib for switch maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating variants and stable disease after first-line chemotherapy. Erlotinib's production information further states that factors associated with prolonged survival should be taken into account when prescribing erlotinib. It further states that no survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumors.

This is written in the approval document as:

Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy

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
2016-01-25	European Medicines Agency	Indication received approval from the European Commission.