Talzenna (talazoparib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Pfizer, Inc. Talzenna (talazoparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf. Revised October 2018. Accessed October 6, 2026.

Regulatory approvals

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

Indication	Statements
TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	BRCA1 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib
FDA (1)	BRCA2 pathogenic variants, HER2-negative	Invasive Breast Carcinoma	Talazoparib