Likelihood of Approval and Phase Transition Success Rate Model – Cabometyx in Gastroesophageal (GE) Junction Carcinomas

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Cabometyx in Gastroesophageal (GE) Junction Carcinomas

Published: November 17, 2023 Report Code: GDHCDR7219LOA-MP-L5

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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.


Cabometyx in Gastroesophageal (GE) Junction Carcinomas Drug Details:

Cabozantinib s-malate (Cabometyx, Aptimetyx) is a s-malate salt form of cabozantinib, acts as an anti-neoplastic agnet. It is formulated as  film-coated tablets for oral route of administration. Cabometyx is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy. Cabozantinib is under development for the treatment of metastatic castration-resistant prostate cancer (MCRPC), non-small cell lung cancer, metastatic renal cell carcinoma, urothelial cell cancer, uterine cancer, high grade leiomyosarcoma, adrenocortical carcinoma, gastroesophageal (GE) junction carcinomas, neuroendocrine tumors, melanoma, cervical cancer, triple-negative breast cancer (TNBC), hepatobiliary system tumor, pancreatic cancer, lip cancer, salivary gland cancer, oral cavity (mouth) cancer, oropharyngeal cancer, nasopharyngeal cancer, paranasal sinus and nasal cavity cancer, laryngeal cancer, muscle invasive bladder cancer (MIBC), soft tissue sarcoma, neuroendocrine gastroenteropancreatic tumors (GEP-NET), neuroendocrine carcinoma, metastatic colorectal cancer, esophageal squamous cell carcinoma (ESCC), neuroblastoma, Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, Wilms” tumor in pediatrics, ovarian cancer, endometrial cancer, gastric cancer, head and neck cancer squamous cell carcinoma, metastatic melanoma, hepatocellular carcinoma, solid tumor, urothelial cell carcinoma, bladder cancer, ureter cancer, urethral cancer, peritoneal cancer, fallopian tube cancer, esophageal cancer.  The drug candidate was under development for the treatment of gastrointestinal stromal tumor (GIST), metastatic hormone-receptor-positive breast cancer, refractory and relapsed multiple myeloma, high-grade glioma, prostate cancer, adenoid cystic carcinoma (ACC), pediatric diffuse intrinsic pontine glioma, medulloblastoma, germ cell tumors.

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.

Quick View – Cabometyx LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Cabometyx
Administration Pathway
· Oral
Therapeutic Areas
· Oncology
Key Manufacturers
· Exelixis Inc
Drug Development Status
· Exelixis Inc

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

    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:

    • 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

    Drug Phase Scope:

    • Phase I, Phase II, Phase III, and Pre-Registration development stage

    Drug Geography Scope:

    • 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”

    Drug Type Scope:

    • Innovator drugs and biosimilars

    Entity Type Scope:

    Only drugs in development by companies are included in the model.

    Exclusion

    • 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.

     

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