Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

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