Talazoparib is under clinical development by Pfizer and currently in Phase II for Refractory Acute Myeloid Leukemia. According to GlobalData, Phase II drugs for Refractory Acute Myeloid Leukemia have a 21% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Talazoparib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
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, metastatic non-squamous non-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, 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.
It was also under development for gastric cancer, peritoneal cancer, ovarian cancer.
Pfizer discovers, develops, manufactures, and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, women’s health, 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, individual provider offices, 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.
For a complete picture of Talazoparib’s drug-specific PTSR and LoA scores, buy the report here.