Last reviewed · How we verify
Talzenna (Talazoparib Tosylate)
PARP1/PARP2 inhibitor causing DNA damage, decreased proliferation, and apoptosis in BRCA-mutated cancers.
Talazoparib is a PARP inhibitor indicated for gBRCAm HER2-negative breast cancer as monotherapy and HRR gene-mutated mCRPC with enzalutamide. It demonstrates linear pharmacokinetics with a 90-hour half-life and primarily renal excretion, requiring dose adjustment in moderate-to-severe renal impairment. P-gp inhibitors significantly increase talazoparib exposure and require dose reduction or avoidance. FDA-approved companion diagnostics are required for patient selection in both indications.
At a glance
| Generic name | Talazoparib Tosylate |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | PARP inhibitor |
| Target | PARP1 and PARP2 enzymes |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| Annual revenue | 182 |
Mechanism of action
Talazoparib inhibits poly(ADP-ribose) polymerase enzymes (PARP1 and PARP2) that play a role in DNA repair. In vitro studies with cancer cell lines harboring defects in DNA repair genes, including BRCA1 and BRCA2, have shown that talazoparib-induced cytotoxicity involves inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes. This results in DNA damage, decreased cell proliferation, and apoptosis. Talazoparib anti-tumor activity was observed in patient-derived xenograft breast cancer models bearing mutated BRCA1 or mutated BRCA2 or wild type BRCA1 and BRCA2.
Approved indications
- Breast Cancer
- HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- BRCA-mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer
Common side effects
- Anemia
- Fatigue
- Platelet count decreased
- Nausea
- Diarrhea
- Weight loss
- White blood cell decreased
- Lymphocyte count decreased
- Anorexia
- Neutrophil count decreased
- Pain
- Alkaline phosphatase increased
Drug interactions
- P-gp inhibitors (itraconazole, amiodarone, carvedilol, clarithromycin, verapamil)
- BCRP inhibitors
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 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 Inc. portfolio CI