Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized dacomitinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating variants.

This is written in the approval document as:

Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

Citation

Pfizer Europe MA EEIG. Vizimpro (dacomitinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/vizimpro-epar-product-information_en.pdf. Revised February 2024. Accessed March 25, 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	Dacomitinib