Likelihood of Approval and Phase Transition Success Rate Model – Epcoritamab in Follicular Lymphoma

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Epcoritamab in Follicular Lymphoma

Published: November 03, 2023 Report Code: GDHCDR5077LOA-MP-L5

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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.


Epcoritamab in Follicular Lymphoma Drug Details:

Epcoritamab-Bysp (Epkinly) is a monoclonal antibody which acts as anti antineoplastic agent. It is formulated as solution for subcutaneous route of administration. Epkinly is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. Epcoritamab (GEN-3013) is under development for the treatment of lymphoma, relapsed and refractory chronic lymphocytic leukemia, Richter’s Syndrome, diffuse large b-cell lymphoma, primary mediastinal b-cell lymphoma, follicular lymphoma, Burkitt-like lymphoma/leukemia, nodal marginal zone b-cell lymphoma, mantle cell lymphoma, marginal zone b-cell lymphoma (nodal marginal zone B-cell lymphoma and extranodal marginal zone B-cell lymphoma), high-grade b-cell lymphoma, small lymphocytic lymphoma and B-cell non-Hodgkin lymphoma, indolent NHL. The drug candidate is administered subcutaneously. It is a bi-specific antibody targeting CD20 and CD3. It is developed based on DuoBody technology that generates stable bi-specific antibody therapeutics.

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 – Epcoritamab LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Epcoritamab
Administration Pathway
· Subcutaneous
Therapeutic Areas
· Oncology
Key Manufacturers
· Genmab AS
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.

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 – Epcoritamab in Follicular Lymphoma
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