Likelihood of Approval and Phase Transition Success Rate Model – Selpercatinib in Central Nervous System (CNS) Tumor

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Selpercatinib in Central Nervous System (CNS) Tumor

Overview

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.


Selpercatinib in Central Nervous System (CNS) TumorDrug Details:

Selpercatinib (Retevmo, Retsevmo) is a potent antineoplastic agent. It is formulated as hard gelatin capsules for the oral route of administration. It is indicated in the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) following prior treatment with immunotherapy and/or platinum-based chemotherapy, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment with cabozantinib and/or vandetanib and with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) and who require systemic therapy following prior treatment with sorafenib and/or lenvatinib.Selpercatinib (LOXO-292) is under development for the treatment of Medullary thyroid cancer, non-small cell lung cancer, anaplastic thyroid cancer, follicular thyroid cancer, papillary thyroid cancer, solid tumors including primary central nervous system tumors, pancreatic cancer, breast cancer, ovarian, small intestine cancer, Carcinoid tumor, salivary gland tumor and lung cancer. The drug candidate is administered through oral route. The drug candidate acts by targeting RET receptor tyrosine kinase.

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 – Selpercatinib LOA Data
Report Segments
· Drug type

· Intervention type

Drug Name
· Selpercatinib
Administration Pathway
· Oral
Therapeutic Areas
· Oncology

Key Manufacturers
· Loxo Oncology Inc
Drug Development Status
· Marketed

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.

Loxo Oncology Inc

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.

     

lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Selpercatinib in Central Nervous System (CNS) Tumor
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Can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company


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