Talazoparib

(Talzenna®)

Talzenna®

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Drug updated on 5/17/2024

Dosage FormCapsule (oral; 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg and, 1 mg)
Drug ClassPoly (ADP-ribose) polymerase (PARP) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.
  • Indicated in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Summary
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  • Talazoparib (Talzenna) is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer, and in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer.
  • The information was derived from 9 systematic reviews and meta-analyses that evaluated talazoparib's safety, effectiveness, indications, and considerations for specific patient subgroups.
  • In comparison to other drugs used for metastatic castration-resistant prostate cancer (mCRPC), talazoparib combined with enzalutamide demonstrates significant benefits in radiographic progression-free survival and overall survival. However, it also has a higher risk of treatment interruption due to adverse events requiring careful patient management.
  • For breast cancer patients carrying germline BRCA mutations who are HER2-negative, talazoparib shows favorable outcomes compared to single-agent chemotherapy, including improved progression-free survival (PFS), overall response rate (ORR), and quality of life, especially among triple-negative hormone receptor-positive subtypes.
  • When comparing safety profiles between PARP inhibitors such as Olaparib, Rucaprib, Niraprib, and Talazoparib, there were no significant differences observed. However, Olaparib might have advantages in reducing risks associated with grade anemia and neutropenia, suggesting different safety profiles could influence treatments based on individual risk factors.
  • These studies highlight the importance of selecting patients for genetic testing to optimize outcomes using this drug, underscoring the necessity of precise subgroup identification to improve therapy effectiveness, manage adverse events, and maximize potential use across a broader range of tumors, independent of their BRCA mutational status, indicating a wider application scope than initially thought.

Product Monograph / Prescribing Information

Document TitleYearSource
Talzenna (talazoparib) Prescribing Information.2024Pfizer Inc., New York, NY

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines