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Talzenna FDA Approval History

Last updated by Judith Stewart, BPharm on July 3, 2023.

FDA Approved: Yes (First approved October 16, 2018)
Brand name: Talzenna
Generic name: talazoparib
Dosage form: Capsules
Company: Pfizer Inc.
Treatment for: Breast Cancer, Prostate Cancer

Talzenna (talazoparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor used for the treatment of BRCA-mutated HER2-negative breast cancer and HRR gene-mutated metastatic castration-resistant prostate cancer.

  • Talzenna is 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.
    - in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
  • Talzenna contains talazoparib which is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a role in DNA repair. Preclinical studies have demonstrated that Talzenna blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth, and cancer cell death.
  • Talzenna capsules are taken orally once daily with or without food.
  • Warnings and precautions associated with Talzenna include myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), myelosuppression, and fetal harm.
  • Common adverse reactions as a single agent include fatigue, nausea, headache, vomiting, alopecia, diarrhea, and decreased appetite. Common laboratory abnormalities include decreased hemoglobin, decreased neutrophils, decreased lymphocytes, decreased platelets, increased glucose, increased aspartate aminotransferase  increased alkaline phosphatase, increased alanine aminotransferase, and decreased calcium.
    Common adverse reactions in combination with enzalutamide include fatigue, nausea, decreased appetite, fractures, dizziness, and dysgeusia. Common laboratory abnormalities include decreased hemoglobin, decreased neutrophils, decreased lymphocytes, decreased platelets, decreased calcium, decreased sodium, decreased phosphate, decreased magnesium, increased bilirubin, and decreased potassium.

Development timeline for Talzenna

Jun 20, 2023Approval Pfizer’s Talzenna (talazoparib) in Combination with Xtandi (enzalutamide) Receives U.S. FDA Approval for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
Oct 31, 2022Senhwa Announces First Patient Successfully Dosed in Phase I Study of Pindnarulex in Combination with Pfizer's Talazoparib for the Treatment of Prostate Cancer
Oct 16, 2018Approval FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
Jun  7, 2018U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation
Dec 13, 2017Talazoparib Significantly Extends Progression-Free Survival in Phase 3 EMBRACA Trial of Patients with Metastatic Breast Cancer
Jun  3, 2017Pfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib in Patients with Germline BRCA-Positive Advanced Breast Cancer

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.