Likelihood of Approval and Phase Transition Success Rate Model – Lurbinectedin in Ewing Sarcoma
Unlock hidden opportunities in the LoA industry
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.
Lurbinectedin in Ewing Sarcoma Drug Details:
Lurbinectedin (Zepzelca) is a synthetic tetrahydropyrrolo [4, 3, 2-de] quinolin-8(1H)-one alkaloid analogue with potential anti-neoplastic activity. It is formulated as lyophilised powder for solution for intravenous route of administration. Zepzelca is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.Lurbinectedin (PM-01183) is under development for the treatment of neuroendocrine gastroenteropancreatic tumors (GEP-NET), advanced or metastatic soft-tissue sarcoma, advanced or metastatic leiomyosarcoma, unresectable non-small cell lung cancer, malignant pleural mesothelioma, small cell lung cancer, HER2 positive metastatic breast cancer, metastatic colorectal cancer, gastric cancer, endometrial cancer, triple-negative breast cancer (TNBC), leukemias, neuroendocrine tumors, relapsed or primary refractory non-M3 acute myeloid leukemia, chronic myeloid leukemia, esophageal cancer, large cell neuroendocrine carcinoma of the lung, pancreatic adenocarcinoma, relapsed/refractory myelodysplastic syndrome, metastatic biliary tract carcinoma, head and neck carcinoma, relapsed or refractoryacute lymphocytic leukemia, germ cell cancer, soft tissue sarcoma, human epidermal growth factor receptor 2 negative breast cancer (HER2- breast cancer), mesothelioma, glioblastoma, Ewing family of tumors, advanced solid tumors, metastatic pancreatic cancer, metastatic urothelial cell carcinoma, synovial sarcoma and neuroendocrine gastroenteropancreatic tumors. It is administered intravenously as a solution concentrate. It is a synthetic alkaloid which targets RNA polymerase II. It was also under development for the treatment of epithelial ovarian cancer peritoneal cancer, fallopian tube cancer, metastatic pancreatic cancer, hepatocellular carcinoma, bone cancer and bladder cancer.
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 – Lurbinectedin LOA Data|
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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.
Drug Phase Scope:
Drug Geography Scope:
Drug Type Scope:
Entity Type Scope:
Only drugs in development by companies are included in the model.
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