Likelihood of Approval and Phase Transition Success Rate Model – Lenalidomide in Relapsed Multiple Myeloma

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Lenalidomide in Relapsed Multiple Myeloma

Published: November 03, 2023 Report Code: GDHCDR11317LOA-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.


Lenalidomide in Relapsed Multiple Myeloma Drug Details:

Lenalidomide (Revlimid) is a thalidomide analogue and an immunomodulatory imide drug (IMiD). It is formulated as hard gelatin capsules for oral route of administration. Revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM), as maintenance therapy in patients with multiple myeloma  following autologous  hematopoietic stem cell transplantation ( auto-HSCT), is indicated for the treatment of  patients with transfusion-dependent anemia due to low -or intermediate -1- risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Revlimid is indicated for the treatment of relapsed or refractory multiple myeloma, in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who are not eligible for stem cell transplant and adult T-cell leukemia-lymphoma. Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL), and marginal zone lymphoma (MZL).Lenalidomide is under development for the treatment of small lymphocytic leukemia (SLL), acute and chronic adult T-cell leukemia/lymphoma, monoclonal B cell lymphocytosis, plasma cell leukemia, relapsed/refractory mantle cell lymphoma, ABC-subtype diffuse large B-cell lymphoma (first-line), relapsed/refractory indolent lymphoma, primary and secondary CNS lymphoma, peripheral T-cell lymphoma, anaplastic large cell lymphoma, chronic lymphocytic leukemia (maintenance, second-line), and in combination with rituximab in relapsed or refractory follicular and mantle cell lymphoma. It was also under development for splenic marginal zone lymphoma, extranodal marginal zone, nodal marginal zone lymphoma, B-cell chronic lymphocytic leukemia (first line), mantle cell lymphoma (first line), diffuse large B-cell lymphoma (maintenance therapy), hormone refractory prostate cancer, cutaneous T Cell Lymphoma, metastatic melanoma, complex regional pain syndrome, radiculopathy, metastatic renal cell carcinoma, Crohn’s disease, ovarian cancer and peritoneal cancer, relapsed or refractory non-hodgkin lymphoma and immunoglobulin G4-related disease (IgG4-RD). It was under development for the treatment of non-deletion 5q myelodysplastic syndrome and follicular lymphoma, acute myelocytic leukemia (AML), papillary thyroid cancer and follicular thyroid cancer, Waldenstrom macroglobulinemia, non-small cell lung cancer, urothelial cell carcinoma, non-muscle-invasive transitional cell bladder cancer, T-cell angioimmunoblastic lymphoma (AITL), myelofibrosis and peripheral T-cell lymphoma (PTCL).

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 – Lenalidomide LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Lenalidomide
Administration Pathway
· Oral
Therapeutic Areas
· Central Nervous System| Gastrointestinal| Immunology| Oncology
Key Manufacturers
· Bristol-Myers Squibb Co
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 – Lenalidomide in Relapsed Multiple Myeloma
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