Likelihood of Approval and Phase Transition Success Rate Model – Sintilimab in Small-Cell Lung 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.
Sintilimab in Small-Cell Lung Cancer Drug Details:
Sintilimab (Tyvyt) is a monoclonal antibody which acts as an anti-neoplastic agent. It is formulated solution for intravenous route of administration. Tyvyt is indicated for the treatment of patients with classical hodgkin’s lymphoma (cHL) that has relapsed or refractory after two or more lines of systemic chemotherapy. It is also indicated in combination of pemetrexed and platinum-based chemotherapy for first-line EGFR or ALK-negative advanced non-squamous NSCLC treatment, combination with gemcitabine and platinum-based chemotherapy is suitable for locally advanced or metastatic squamous forms that are not resectable first-line treatment of NSCLC and in combination with bevacizumab for the first-line treatment of hepatocellular carcinoma. Tyvyt is indicated in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).IBI-308 is under development for the treatment of recurrent or metastatic angiosarcoma, recurrent glioblastoma, metastatic undifferentiated pleomorphic sarcoma, mucoepidermoid carcinoma, acinic cell carcinoma, oral cavity squamous cell carcinoma and oropharyngeal squamous cell carcinoma, squamous non-small cell lung cancer, salivary gland cancer, adenoid cystic carcinoma, hepatocellular carcinoma, rectal cancer, advanced metastatic urothelial carcinoma, triple negative breast cancer, recurrent and or metastatic head and neck squamous cell carcinoma, higher-risk myelodysplastic syndrome, endometrial cancer, hepatocellular carcinoma (HCC), EBV-associated lymphoproliferative disease including relapse/refractory EBV-related hemophagocytic syndrome, non-metastatic rectal cancer, muscle invasive bladder cancer (MIBC), acral melanoma, advanced pancreatic cancer, brain tumor, melanoma, melanoma (adjuvan) therapy, primary mediastinal B-cell lymphoma, peripheral T-cell lymphomas, intrahepatic cholangiocarcinoma, metastatic renal cell carcinoma, classic Hodgkin’s lymphoma, various tumor types including dedifferentiated liposarcoma, nasopharyngeal cancer, neuroendocrine tumors gastric cancer, melanoma, metastatic esophageal squamous cell carcinoma, bladder cancer, small-cell lung cancer, metastatic colorectal cancer, endometrial cancer, adenocarcinoma of the gastroesophageal junction, hepatocellular carcinoma, squamous non-small cell lung cancer, non-squamous non-small cell lung cancer, cervical cancer, thoracic malignancies, recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal adenocarcinoma, gallbladder cancer and dMMR/MSI-H Stage III colorectal cancer, metastatic cutaneous melanoma and metastatic pancreatic cancer. It is administered intravenously. The drug candidate is a monoclonal antibody and targets immune checkpoint, programmed cell death protein 1 (PD1). It was also under development for Non-Hodgkin lymphoma, kidney cancer and metastatic prostate cancer, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma.
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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