Likelihood of Approval and Phase Transition Success Rate Model – Durvalumab in Extrahepatic Bile Duct Cancer
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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.
Durvalumab in Extrahepatic Bile Duct Cancer Drug Details:
Durvalumab (MEDI-4736, Imfinzi, Fidursi, Imfinzio) a programmed death-ligand 1 (PD-L1) blocking antibody. It is formulated as solution and concentrate solution for intravenous route of administration. Imfinzi is indicated as maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC). and for the treatment of patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT), 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide), and adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin.It is under development for the treatment of advanced or metastatic papillary renal cell carcinoma, poorly differentiated thyroid carcinoma, anaplastic thyroid cancer, follicular thyroid cancer, medullary thyroid cancer and papillary thyroid cancer, HER2 negative metastatic breast cancer, esophageal squamous cell carcinoma, secondary central nervous system lymphoma and secondary diffuse large B-cell lymphoma (DLBCL), pulmonary sarcomatoid carcinoma, bile duct cancer, non-small cell lung cancer, esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma, metastatic biliary tract cancer, esophageal cancer, adenocarcinoma of the gastro-esophageal junction, renal cell carcinoma, epithelial ovarian cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, muscle invasive bladder cancer (MIBC), mycosis fungoides, sezary syndrome, malignant pleural mesothelioma, small-cell lung cancer, non-muscle invasive bladder cancer (NMIBC) (superficial bladder cancer), endometrial cancer, diffuse large b-cell lymphoma, primary mediastinal B-cell lymphoma, follicular thyroid cancer, oropharyngeal cancer, human papillomavirus (HPV) associated cancer, primary mediastinal b-cell lymphoma, germ cell tumors, soft tissue sarcoma, transitional cell carcinoma (urothelial cell carcinoma), b-cell chronic lymphocytic leukemia, lymphoma, refractory multiple myeloma, relapsed multiple myeloma, B-cell non-Hodgkin lymphoma, breast cancer, triple-negative breast cancer, endometrial cancer, hormone-sensitive prostate cancer, esophageal cancer, primary CNS lymphoma, anaplastic large cell lymphoma, neuroblastoma, small-cell lung cancer, malignant pleural mesothelioma, fallopian tube cancer, peritoneal cancer, oropharyngeal cancer, metastatic adenocarcinoma of the pancreas, vulvar cancer, vaginal cancer, human papillomavirus (HPV) associated cancer, gastric cancer, esophageal cancer, melanoma, oral cavity (mouth) cancer, leiomyosarcoma, gallbladder cancer, metastatic melanoma, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, metastatic biliary tract cancer, papillary renal cell carcinoma, metastatic renal cell carcinoma, transitional cell carcinoma (urothelial cell carcinoma), angiosarcoma, dedifferentiated liposarcoma, osteosarcoma, ureter cancer, urethral cancer, chronic lymphocytic leukemia (CLL).It was also under development for solid tumors, metastatic breast cancer, metastatic castration-resistant prostate cancer, metastatic colorectal cancer, bladder carcinoma, ovarian cancer, mantle cell lymphoma, Hodgkin lymphoma, myelodysplastic syndrome, acute myelocytic leukemia, metastatic cervical cancer, pancreatic ductal adenocarcinoma, neuroendocrine tumor, multiple myeloma (Kahler disease) as firstline therapy, Epstein-Barr virus positive (EBV+) nasopharyngeal carcinoma, glioblastoma multiforme, relapsed and refractory multiple myeloma, diffuse large B-cell lymphoma, peripheral T-cell lymphomas (PTCL), Post-Polycythemia Vera myelofibrosis (PPV-MF), post-essential thrombocythemia myelofibrosis (POST-ET MF), primary myelofibrosis, B-cell chronic lymphocytic leukemia, lymphoma and recurrent head and neck cancer squamous cell carcinoma, small-cell lung cancer, non-small cell lung cancer and unspecified 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!
- 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
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