Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that EGFR activating variants status confers therapeutic sensitivity to Afatinib in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized afatinib as a monotherapy indicated for the treatment of EGFR TKI-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR variants.

This statement is based on a regulatory approval from the European Medicines Agency:

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).

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.

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.