Regulatory approval

Published by the European Medicines Agency. Approved

GIOTRIF as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).

This is written in the approval document.

Citation

Boehringer Ingelheim International GmbH. Giotrif (afatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/giotrif-epar-product-information_en.pdf. Revised June 2023. Accessed March 7, 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	Afatinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2013-09-25	European Medicines Agency	Indication received approval from the European Commission.