Likelihood of Approval and Phase Transition Success Rate Model – Lenvatinib Mesylate in Metastatic Melanoma

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Lenvatinib Mesylate in Metastatic Melanoma

Published: November 17, 2023 Report Code: GDHCDR10132LOA-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.


Lenvatinib Mesylate in Metastatic Melanoma Drug Details:

Lenvatinib mesylate (Lenvima / Kisplyx / Lenvixi) is a pyrrolopyrimidine derivative acts as anti-neoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Lenvima is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). Lenvima is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentioated (papillary, follicular, Hurthel cell) thyroid carcinoma refractory to radioactive iodine and Kisplyx is indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy and for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy and indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Lenvima is indicated for the treatment of unresectable thymic carcinoma and also indicated in combination with pembrolizumab for the first-line treatment of adult patients with advanced renal cell carcinoma.It is also under development for the treatment of advanced adrenocortical cancer, malignant pleural mesothelioma, advanced/metastatic gastric cancer, metastatic esophageal squamous cell carcinoma, gastroesophageal junction adenocarcinoma, melanoma, recurrent or metastatic head and neck squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, and/or larynx, locally advanced or metastatic gastrointestinal Stromal Tumor (GIST), pediatric diffuse intrinsic pontine glioma, recurrent or metastaticsalivary gland cancers, anaplastic thyroid cancer, merkel cell carcinoma, pancreatic ductal adenocarcinoma, relapsed and refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, medulloblastoma, ependymoma, high grade glioma, breast cancer, triple-negative breast cancer, endometrial cancer, renal cell carcinoma (second line), hepatocellular carcinoma, bladder cancer, locally advanced or metastatic non-squamous non-small cell lung cancer, endometrial cancer, urothelial cancer, biliary tract cancer, advanced gastric cancer, adenoid cystic carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer (RET translocations), thymic carcinoma, endometrial cancer, fallopian tube cancer, peritoneal cancer, recurrent head and neck cancer squamous cell carcinoma, colorectal cancer, cutaneous squamous cell carcinoma and epithelial ovarian cancer, ampullary carcinoma, gallbladder carcinoma, prostate cancer, HER2 negative breast cancer, human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP) and leptomeningeal metastases from any solid tumor and mixed carcinoma. It is also under development for solid tumors in combination with pembrolizumab and for advanced or metastatic non clear cell renal cell carcinoma who have not received any chemotherapy for advanced disease. It was also under development for the treatment of non-small cell lung cancer, lung adenocarcinoma, recurrent malignant glioma, liver fibrosis, endometrial cancer (monotherapy), melanoma and recurrent glioblastoma, metastatic melanoma, peripheral primitive neuroectodermal tumor (pPNET) and non-small cell lung cancer (third-line, monotherapy).

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 – Lenvatinib Mesylate LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Lenvatinib Mesylate
Administration Pathway
· Oral
Therapeutic Areas
· Gastrointestinal| Infectious Disease| Oncology
Key Manufacturers
· Eisai Co Ltd
Drug Development Status
· Eisai Co Ltd

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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