Talazoparib

Talazoparib (Talzenna, Pfizer Europe MA EEIG) has 2 EU-approved indications in 2 tumour types. 1 needs a biomarker result: BRCA1/2 (1).
Approved indications of Talazoparib
Biomarker requirementRegimenSettingConditions
Breast cancer1
Germline BRCA1/2-mutations, HER2-negative
Monotherapy
Any line
advanced
Previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless not suitable; prior endocrine-based therapy for HR-positive breast cancer unless considered unsuitable
Prostate cancer1
None
+ enzalutamide
1L
metastatic
Castration-resistant only; Chemotherapy is not clinically indicated
Full text of section 4.1 (therapeutic indications)

Breast cancer 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. Prostate cancer Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Label history

13 changes to the Talzenna label since 2020, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes