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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	EGFR oncogenic variants	Non-Small Cell Lung Cancer	Afatinib