Likelihood of Approval and Phase Transition Success Rate Model – Ipilimumab in Chronic Lymphocytic Leukemia (CLL)
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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.
Ipilimumab in Chronic Lymphocytic Leukemia (CLL) Drug Details:
Ipilimumab (Yervoy, Winglore) is a recombinant, human monoclonal antibody belongs to antineoplastic agent. It is formulated as solution, powder for solution and concentrate solution for intravenous route of administration. It is indicated for the treatment of unresectable or metastatic melanoma. Yervoy also used as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Yervoy in combination with opdivo (nivolumab) is indicated for the treatment of unresectable or metastatic melanoma in previously untreated adults. It is also indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years of age and older, and nivolumab (Opdivo) in combination with ipilimumab (Yervoy), as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(=1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and also nivolumab in combination with ipilimumab ( and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Yervoy in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult patients. Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer.The drug candidate is under development for the treatment of chronic lymphocytic leukemia (CLL), homologous-recombination deficient (HRD) metastatic adenocarcinoma of the pancreas, Richter transformation (RT), relapsed/refractory multiple myeloma, hepatocellular carcinoma, gastric cancer, metastatic neuroendocrine prostate cancer (NEPC), metastatic advanced uveal melanoma, neurofibromatosis type 1 (NF1), malignant peripheral nerve sheath tumors (MPNST), metastatic urothelial carcinoma, metastatic renal cell carcinoma, cutaneous melanoma, glioblastoma multiforme (GBM), gliosarcoma, Merkel cell carcinoma, solid tumors including liver cancer, lung cancer and adrenal gland cancer, chronic myelocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, Hodgkin lymphoma, acute myelocytic leukemia, acute lymphocytic leukemia, myelodysplastic syndrome and chronic lymphocytic leukemia. Yervoy in combination with Opdivo is indicated for the first-line treatment of unresectable, advanced or recurrent esophageal cancer in adults. Yervoy in combination with Opdivo as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).It was also under development for transitional cell cancer (urothelial cell cancer, breast cancer, adenocarcinoma, squamous non-small cell lung cancer, metastatic prostate cancer (as a first line therapy), metastatic hormone refractory (castration-resistant, androgen-independent) prostate cancer, ovarian cancer and melanoma. It was under development for the treatment of human immunodeficiency virus (HIV) infection and diffuse large B 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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