Likelihood of Approval and Phase Transition Success Rate Model – Cobimetinib Fumarate in Soft Tissue Sarcoma
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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.
Cobimetinib Fumarate in Soft Tissue Sarcoma Drug Details:
Cobimetinib (GDC-0973 / RG7421 / Cotellic) acts as an anti neoplastic agent. It is formulated as film coated tablets and tablets for oral route of administration. Cotellic is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.The drug candidate is under development for the treatment of extracranial arteriovenous malformations (AVM), atypical teratoid rhabdoid tumor, hairy cell leukemia, chronic myelomonocytic leukemia, non-small cell lung cancer (first and third-line therapy), histiocytic disorders such as Langerhans cell histiocytosis and other histiocytic disorders such as juvenile xanthogranuloma (JXG), Erdheim-Chester disease (ECD) and Rosai-Dorfman Disease (RDD)), craniopharyngioma, glioma, high-grade glioma, low-grade glioma, epithelial ovarian, fallopian tube, and primary peritoneal cancer, pediatric diffuse intrinsic pontine glioma, stages I-III non-small cell lung cancer with ALK, ROS1, NTRK, or BRAF v600E molecular alterations, pancreatic ductal adenocarcinoma, rhabdomyosarcoma, non-rhabdomyosarcoma, brenner tumor, soft tissue sarcomas Neuroblastoma Melanoma Malignant peripheral nerve sheath tumor Rhabdoid tumors, including atypical teratoid/rhabdoid tumor (ATRT) NF1-associated tumor (including plexiform neurofibroma), schwannoma, renal cell carcinoma, head and neck squamous cell carcinoma, urothelial carcinoma, relapsed and refractory acute myeloid leukemia, metastatic inflammatory breast cancer, HER-2 positive breast cancer and relapsed and refractory multiple myeloma. It was also under development for BRAF mutated metastatic melanoma (first line of therapy), endometrial cancer, metastatic colorectal cancer and metastatic triple negative breast cancer (first line of therapy). It is administered through oral and intravenous route.
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. GlobalDatas 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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