Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRCA1 pathogenic variants and HER2-negative status confers therapeutic sensitivity to Talazoparib in patients with Invasive Breast Carcinoma.

The U.S. Food and Drug Administration granted approval to talazoparib for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for Talazoparib.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

Citation

Pfizer, Inc. Talzenna (talazoparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211651s012lbl.pdf. Revised February 2024. Accessed October 30, 2024. 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.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-10-16	Food and Drug Administration	Indication received traditional approval.