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Talzenna (talazoparib)
Talzenna blocks PARP enzymes, which are involved in DNA repair, to prevent cancer cell growth.
Talzenna (talazoparib) is a small molecule Poly(ADP-Ribose) Polymerase Inhibitor developed by Pfizer, targeting PARP4. It was FDA-approved in 2018 for the treatment of germline BRCA-mutated, HER2-negative metastatic breast cancer. Talzenna is a patented medication with no generic manufacturers available. Key safety considerations include potential side effects such as anemia, fatigue, and neutropenia. As a PARP inhibitor, Talzenna works by blocking the action of PARP enzymes, which are involved in DNA repair.
At a glance
| Generic name | talazoparib |
|---|---|
| Sponsor | Pfizer |
| Drug class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Target | Poly [ADP-ribose] polymerase 4 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2018 |
| Annual revenue | 182 |
Mechanism of action
Talazoparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play role in DNA repair. In vitro studies with cancer cell lines that harbored defects in DNA repair genes, including BRCA and BRCA 2, have shown that talazoparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, decreased cell proliferation, and apoptosis. Talazoparib anti-tumor activity was observed in human patient-derived xenograft breast cancer tumor models bearing mutated BRCA or mutated BRCA or wild-type BRCA and BRCA 2.
Approved indications
- Germline BRCA-mutated, HER2-negative metastatic breast cancer
Common side effects
- Fatigue
- Anemia
- Neutropenia
- Thrombocytopenia
- Decreased appetite
- Headache
- Nausea
- Vomiting
- Diarrhea
- Alopecia
- Decrease in hemoglobin
- Decrease in leukocytes
Key clinical trials
- Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations (PHASE2)
- Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial (PHASE2)
- Testing Maintenance Therapy for Small Cell Lung Cancer in Patients With SLFN11 Positive Biomarker (PHASE2)
- TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (PHASE2)
- A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients
- Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer. (PHASE1,PHASE2)
- Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial (PHASE1)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Talzenna CI brief — competitive landscape report
- Talzenna updates RSS · CI watch RSS
- Pfizer portfolio CI