Talazoparib is under clinical development by Pfizer and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Talazoparib’s likelihood of approval (LoA) and phase transition for Malignant Pleural Mesothelioma took place on 20 Sep 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Talazoparib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Talazoparib overview

Talazoparib (Talzenna) is an anti-neoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Talzenna is indicated for the treatment of adult patients with deleterious, suspected deleterious germline breast cancer susceptibility gene (BRCA) -mutated ( gBRCAm ) human epidermal growth factor receptor 2 (HER2)- negative locally advanced or metastatic breast cancer with a mutation in homologous-recombination deficient (HRD) pathway genes, and as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

Talazoparib (BMN-673) is under development for the treatment of malignant pleural mesothelioma, advanced or metastatic solid tumor, myelodysplastic syndrome, genetically defined cancers including gastric cancer, triple-negative breast cancer, pancreatic cancer, metastatic castration-resistant prostate cancer, small-cell lung cancer, acute myeloid leukemia (AML), HER2 negative breast cancer, epithelial ovarian cancer, relapsed or refractory Ewing's sarcoma, cervical cancer, metastatic breast cancer, hormone-sensitive prostate cancer, colorectal cancer, gastroesophageal junction adenocarcinoma, metastatic urothelial carcinoma, renal pelvis cancer, upper urinary tract cancer and bladder cancer, urethral cancer. The drug candidate is administered orally, and it is a new molecular entity (NME). BMN-673 is a Poly ADP-ribose polymerase (PARP) inhibitor. It was also under development for pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), myelodysplastic syndrome (MDS), chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), colorectal cancer, epithelial ovarian cancer, peritoneal cancer, fallopian tube cancer, Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer and glioblastoma multiforme.

Pfizer overview

Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa and the Middle East. Pfizer is headquartered in New York, the US.

Quick View Talazoparib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Talazoparib
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Pfizer
  • Originator: LEAD Therapeutics
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.