Dacomitinib

Dacomitinib (Vizimpro, Pfizer Europe MA EEIG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: EGFR (1).
Approved indications of Dacomitinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
EGFR-activating mutation
Monotherapy
1L
advanced
None
Full text of section 4.1 (therapeutic indications)

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.

Label history

5 changes to the Vizimpro label since 2021, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes