Likelihood of Approval and Phase Transition Success Rate Model – Venetoclax in Ewing Sarcoma
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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.
Venetoclax in Ewing Sarcoma Drug Details:
Venetoclax (ABT-199, GDC-0199/RG7601, Venclexta, Venclyxto) acts as an antineoplastic agent. It is formulated as film coated tablets and coated tablets for oral route of administration. Venclexta is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL in the absence of 17p deletion or TP53mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor, and Venclyxto in combination with rituximab is indicated for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. It is used as monotherapy in adults for the treatment of chronic lymphocytic leukemia (CLL), a 1 7p – deletion or TP53 having mutation and under a treatment with an inhibitor of the B – showed a treatment failure cell receptor signaling pathway, and also indicated in combination with azacitidine, ordecitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy and indicated for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Venclexta is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta is indicated for the treatment of acute myeloid leukemia (AML). It is under development for the treatment of newly diagnosed Ph-like B cell acute lymphoblastic leukemia, relapsed or refractory light chain amyloidosis, relapsed and refractory mantle cell lymphoma, small cell lung cancer, acute myeloid leukemia, follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), newly diagnosed marginal zone lymphoma, acute myeloid leukemia in first remission after conventional chemotherapy, nom-small cell lung cancer as first line therapy, primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphoma and extranodal MALT lymphoma, diffuse large B-cell lymphoma, frontline, relapsed or refractory myelodysplastic syndrome, DLBCL, metastatic breast cancer, t-cell acute lymphocytic leukemia and relapsed and refractory chronic lymphocytic leukemia (CLL), solid tumors, rhabdomyosarcoma, Ewing sarcoma, Wilms’ tumor (nephroblastoma). It was also under development for follicular lymphoma as first line therapy. It is a new molecular entity (NME). It was under development for non-small cell lung cancer and angioimmunoblastic T-cell lymphoma (AITL). It was also under development for the treatment of human epidermal growth factor receptor 2 negative breast cancer (her2- breast cancer) and relapsed and refractory multiple myeloma.
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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