Likelihood of Approval and Phase Transition Success Rate Model – Apatinib Mesylate in Gastroesophageal (GE) Junction Carcinomas
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How likely is it that a drug will get approved? Will the drug transition to the next phase of its clinical pathway? 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.
Apatinib Mesylate in Gastroesophageal (GE) Junction Carcinomas Drug Details:
Apatinib Mesylate (Aitan) is an anti-neoplastic agent. It is formulated as film-coated tablets for oral route of administration. Apatinib is indicated in treatment for metastatic gastric cancer and hepatocellular carcinoma.Apatinib (YN968D1) is under development for the treatment of advanced right-sided colon cancer, retroperitoneal sarcomas, osteosarcoma, liver metastasis of gastrointestinal pancreatic neuroendocrine tumor (GEP-NET), neuroendocrine tumors, metastatic pancreatic cancer, soft tissue sarcoma, metastatic hepatocellular carcinoma, metastatic gastric cancer, adenocarcinoma of gastroesophageal junction, metastatic adenoid cystic carcinoma, relapsed/refractory non-squamous non-small cell lung cancer (NSCLC), metastatic colorectal cancer, gestational trophoblastic neoplasia(GTN), intrahepatic cholangiocarcinoma, small-cell lung cancer, metastatic triple-negative breast cancer, progressive/metastatic refractory thyroid cancer, epithelial ovarian cancer, esophageal squamous cell carcinoma, metastatic head and neck squamous cell carcinoma, metastatic esophageal squamous cell carcinoma, recurrent cervical cancer, endometrial cancer, relapsed or refractory extranodal nasal type NK/T cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma, non-metastatic nasopharyngeal carcinoma (NPC) that have residual Epstein-Barr virus (EBV), gallbladder cancer, thymic epithelial tumor, recurrent high-grade glioma, papillary thyroid cancer, medullary thyroid cancer, follicular thyroid cancer, recurrent glioblastoma multiforme, advanced lung adenocarcinoma, advanced malignant melanoma, metastatic advanced biliary tract carcinoma, urothelial carcinoma, peritoneal cancer, fallopian tube cancer renal cell carcinoma and primary pulmonary lymphoepithelioid carcinoma, synovial sarcoma, leiomyosarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, dermatofibrosarcoma protuberans, Ewing’s sarcoma /primary neural ectoderm tumors, desmoplastic small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroma, gastroesophageal (GE) junction carcinomas and radiation-induced brain injury. It was also under development for the treatment of gastrointestinal stromal tumor (GIST), NSCLC, triple negative breast cancer and colorectal 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
- Predict the specific likelihood of approval and phase transition success rates of a drug using a combination of machine learning and proprietary models
- Get information on LOA and PTSR for competitors’ drugs to plan your clinical development, commercialization and marketing strategies
- Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR
- Use PTSR and LOA information and event-driven changes for your investment decisions.
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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