Talzenna

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talazoparib

Authorised
This medicine is authorised for use in the European Union.

Overview

Talzenna is a cancer medicine used on its own to treat a type of breast cancer (HER2-negative with BRCA mutations) that has spread beyond the original site, in patients who have been treated with certain medicines which have stopped working or when these medicines are not suitable.

Talzenna contains the active substance talazoparib.

This EPAR was last updated on 08/07/2019

Authorisation details

Product details
Name
Talzenna
Agency product number
EMEA/H/C/004674
Active substance
talazoparib
International non-proprietary name (INN) or common name
talazoparib
Therapeutic area (MeSH)
Breast Neoplasms
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union
20/06/2019
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

Talzenna - EMEA/H/C/004674 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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 (see section 5.1). 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.

Assessment history

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