Likelihood of Approval and Phase Transition Success Rate Model – Niraparib in Metastatic Biliary Tract Cancer
Powered by
Unlock hidden opportunities in the LoA industry
Empower your strategies with our Likelihood of Approval and Phase Transition Success Rate Model – Niraparib in Metastatic Biliary Tract Cancer report and make more profitable business decisions.
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.
Niraparib in Metastatic Biliary Tract Cancer Drug Details:
Niraparib (MK-4827, Zejula) is an anti-neoplastic agent. It is formulated as hard gelatin capsules, tablets and film coated tablets for oral route of administration. Zejula is indicated for the treatment of adult patients with recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy and also indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous-recombination deficient (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.It is under development for the treatment of advanced rectal cancer, recurrent glioblastoma, astrocytoma, oligodendroglioma, high-grade neuroendocrine carcinoma, advanced non-small cell lung cancer, refractory osteosarcoma, neuroblastoma, adrenocortical carcinoma, rhabdomyosarcoma, recurrent and metastatic nasopharyngeal carcinoma, metastatic castration-sensitive prostate cancer (mCSPC), recurrent and metastatic head and neck squamous cell carcinoma, recurrent glioblastoma, solid tumor, ovarian cancer, fallopian tube cancer, prostate cancer, pancreatic cancer, peritoneal cancer, metastatic urothelial cancer, gastric adenocarcinoma and gastroesophageal junction adenocarcinoma, metastatic colorectal cancer, melanoma, advanced or metastatic solid tumors, metastatic invasive carcinoma of the cervix, esophageal cancer, gastroesophageal Junction and proximal gastric adenocarcinoma, uterine serous carcinoma, metastatic pancreatic cancer, recurrent epithelial ovarian, fallopian tube, metastatic pancreatic ductal adenocarcinoma, primary peritoneal cancer, solid tumors, small cell lung cancer, Ewing’s sarcoma, metastatic castration-resistant prostate cancer (CRPC), squamous non-small cell lung cancer, endometrial cancers, soft tissue sarcoma with at least one line of prior chemotherapy, mesothelioma, uveal melanoma, renal cell carcinoma and cholangiocarcinoma, metastatic biliary tract cancer and pancreatic cancer. It is a new molecular entity (NME).It was under development for the treatment of mantle cell lymphoma, breast cancer, HR positive and HER2 negative recurrent gBRCA positive breast cancer, metastatic triple negative breast 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.
Quick View – Niraparib LOA Data | |||||
Report Segments |
|
||||
Drug Name |
|
||||
Administration Pathway |
|
||||
Therapeutic Areas |
|
||||
Key Manufacturers |
|
||||
Drug Development Status |
|
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!
- Well-informed Investment Decisions: This data helps you navigate the dynamic landscape of drug development and regulatory considerations.
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”
- Innovator drugs and biosimilars
- Diagnostics, Imaging Agents, Biomarkers, stents and other drug delivery devices (covered in GlobalData’s Medical Intelligence Center).
- Nutraceuticals, dietary supplements, alternative medicines, imaging agents, radio emitter, transplants, transfusions, fillers, cosmetics, probiotics, antiseptics, antacids, mobilizing agents, veterinary drugs and drugs not seeking approval.
- Generic drugs
- Innovative drugs in Preclinical or Discovery Stage.
- Pipeline drugs sponsored by a Government or Institution.
- Drugs with a specific Drug Geography not the United States.
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
Get in touch to find out about multi-purchase discounts
reportstore@globaldata.com
Tel +44 20 7947 2745