Giotrif (afatinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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).	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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