Likelihood of Approval and Phase Transition Success Rate Model – Eribulin Mesylate in Peripheral Nerve Sheath Tumor (Neurofibrosarcoma)
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Overview
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.
Eribulin mesylate in Peripheral Nerve Sheath Tumor (Neurofibrosarcoma) Drug Details:
Eribulin mesylate (E-7389, Halaven,Teceris) is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. It is formulated as a solution for the intravenous route of administration. It is indicated for the treatment of patients with locally advanced or metastatic breast cancer and unresectable or metastatic liposarcoma (leiomyosarcoma) who have received a prior anthracycline-containing regimen. Halaven is also indicated for the treatment of patients with soft tissue sarcoma.It is under development for the treatment of solitary firbous tumor, metastatic urothelial cell cancer, advanced metastatic breast cancer, recurrent or refractory solid tumors including lymphomas, glioblastoma, soft tissue sarcoma, relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and ewing sarcoma (EWS), triple negative breast cancer, angiosarcoma, 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 protuberance, Ewing sarcoma/primary neuroectodermal tumor, desmoplastic circle Cellular tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroma and pregressive epitheloid hemangioendothelioma (EHE). It was also under development for the treatment of HER2 positive breast cancer, HER2 negative breast cancer, metastatic hormone refractory prostate cancer, ovarian cancer, uterine cancer and non-small cell lung cancer that has progressed following two or more prior treatment regimens and bladder cancer, transitional cell cancers of the urothelium including prostate, urethra, ureter, and renal pelvis cancers.
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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