Likelihood of Approval and Phase Transition Success Rate Model – Abemaciclib in Ewing Sarcoma

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Abemaciclib in Ewing Sarcoma

Published: November 03, 2023 Report Code: GDHCDR11389LOA-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.


Abemaciclib in Ewing Sarcoma Drug Details:

Abemaciclib (Verzenio / Verzenios / Yulareb) is a benzimidazole derivative, acts as an anti-tumor or anti-neoplastic agent. It is formulated as tablets and film coated tablets for the oral route of administration. Verzenio is indicated in combination with fulvestrant for the treatment of women with hormone receptor positive and HER2 negative advanced or metastatic breast cancer with disease progression following endocrine therapy. It is also indicated as monotherapy for the treatment of adult patients with hormone receptor positive and HER2 negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting and also indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor positive and HER2 negative advanced or metastatic breast cancer. Verzenio is indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, nodepositive, early breast cancer at high risk of recurrence and a Ki-67 score =20% as determined by an FDA approved test.It is under development for the treatment of high-risk metastatic hormone-sensitive prostate cancer, Kaposi sarcoma, metastatic gastroesophageal junction adenocarcinoma, neuroblastoma, platinum-resistant ovarian cancer, adenocarcinoma of the prostate, neurofibromatosis 1, metastatic biliary tract carcinoma, esophageal cancer, cholangiocarcinoma, urothelial cancer, metastatic castration-resistant prostate cancer, advanced and metastatic solid tumors such as colorectal cancer, relapsed/ refractory multiple myeloma, metastatic melanoma, glioblastoma multiforme, astrocytoma, meningioma, ependymoma, oligodendroglioma, lymphoma, primary CNS lymphoma, IDH mutant glioma, recurrent head, and neck squamous cell carcinoma, Hormone receptor positive and HER2 negative breast cancer, metastatic breast cancer, HER2 positive breast cancer, endometrial cancer, malignant mesothelioma,  relapsed or refractory mantle cell lymphoma, non-small cell lung cancer including squamous non-small cell lung cancer, neuroendocrine tumors, metastatic renal cell carcinoma, pediatric diffuse intrinsic pontine glioma, dedifferentiated liposarcoma, gastric cancer,  Ewing’s sarcoma, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, adipocytic sarcoma and gastroesophageal junction adenocarcinoma. The drug candidate is a new chemical entity (NCE). It was under development for the treatment of pancreatic ductal adenocarcinoma, hepatocellular carcinoma and human epidermal growth factor receptor 2 (HER2) positive, early breast cancer.

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 – Abemaciclib LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Abemaciclib
Administration Pathway
· Oral
Therapeutic Areas
· Genetic Disorders| Infectious Disease| Oncology
Key Manufacturers
· Eli Lilly and 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.

     

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