Therapeutic Response Statement (Sensitivity)

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

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

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.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2019-04-02	European Medicines Agency	Indication received approval from the European Commission.