Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized talazoparib 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 endrocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

This is written in the approval document as:

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.

Citation

Pfizer Europe MA EEIG. Talzenna (talazoparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/talzenna-epar-product-information_en.pdf. Revised January 2024. Accessed March 23, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib
Sensitivity (+)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib