Regulatory approval

Published by the European Medicines Agency.

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 is written in the approval document as:

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.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR oncogenic variants	Non-Small Cell Lung Cancer	Afatinib