Likelihood of Approval and Phase Transition Success Rate Model – Talazoparib in Adenocarcinoma Of The Gastroesophageal Junction
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This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.
Talazoparib in Adenocarcinoma Of The Gastroesophageal Junction Drug Details:
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.
Report Coverage
The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.
The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.
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Reasons to Buy
- Precise Likelihood of Approval and Phase Transition Success Rates: Our machine learning and proprietary models provide accurate predictions, helping you gauge the potential success of a drug in the regulatory process.
- Competitive Strategy Planning: Access information on LOA and PTSR for competitors’ drugs, allowing you to plan your clinical development, commercialisation and marketing strategies
- Event-driven Updates: Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR. Get the latest insights to adapt your strategies promptly!
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Scope
- Drug Details: Drug name, Drug type, Intervention type
- Administration Pathway
- Therapeutic Areas
- Key Manufacturers
- Drug Development Status
This is an on-demand report that will be delivered upon request. The report will be delivered within 2 business days of the purchase, excluding weekends and holidays. Certain sections of the report may be removed or altered based on data availability and relevance.
Frequently asked questions
- Drugs which have been approved in the past 10 years
- Drugs which have failed during clinical development in the past 18 years
- Drugs which are currently in development
- Phase I, Phase II, Phase III, and Pre-Registration development stage
- Drugs must meet one of the following criteria to be included in the model:
- The developer has specified the US as an intended market for approval.
- The developer has not specified any country as an intended market for approval, i.e. the “Drug Geography” is listed as “Global”
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The probability of a drug ultimately receiving market authorization
The probability of a drug’s advancement to the next stage of clinical development
GlobalData’s Drug-Specific Likelihood of Approval (LoA) calculates the Phase Transition Success Rate (PTSR) and Likelihood of Approval (LoA) customized to individual drug. The model uses a combination of Machine Learning (ML) and a GlobalData proprietary algorithm to process data points from the Drugs, Clinical Trials, Regulatory Milestones, Company, and Financial databases.
Inclusion
Data Scope:
Drug Phase Scope:
Drug Geography Scope:
Drug Type Scope:
Entity Type Scope:
Only drugs in development by companies are included in the model.
Exclusion
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