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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib
EMA (1)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib