Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 22 July 2019

Indication(s)

Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

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Category Value
Agency product number EMEA/H/C/004674
Orphan designation No
Date First Approved 20-06-2019
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Pfizer Europe MA EEIG