Talzenna (talazoparib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

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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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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