Likelihood of Approval and Phase Transition Success Rate Model – Disitamab Vedotin in Kidney Cancer (Renal Cell Cancer)

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Disitamab Vedotin in Kidney Cancer (Renal Cell Cancer)

Published: November 03, 2023 Report Code: GDHCDR3554LOA-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.


Disitamab Vedotin in Kidney Cancer (Renal Cell Cancer) Drug Details:

Disitamab vedotin (Aidexi) is an antibody-conjugated drug that contains the human epidermal growth factor receptor-2 (HER2) antibody portion, linker and the cytotoxic drug monomethyl auristatin E (MMAE). It is developed based on antibody-drug conjugates technology. It is formulated as solution for injection for intravenous route of administration. Aidexi is indicated for the treatment of locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) with HER2 over-expression in patients who have received at least two types of systemic chemotherapy.Disitamab vedotin (RC-48) is under development for the treatment of solid tumors including breast cancer, HER2 expressing non-small cell lung cancer, non-muscle invasive bladder cancer (NMIBC), metastatic liver cancer, advanced or metastatic urothelial carcinoma of unresectable origin including urothelial carcinoma of bladder, ureter cancer, renal pelvis cancer, and urethral cancer, advanced melanoma, advanced or metastatic HER2 expressing biliary tract cancer, bile duct cancer, gallbladder cancer, muscle invasive bladder cancer (MIBC), HER2 expressing urothelial carcinoma and HER2 low to non expressing urothelial cancer, metastatic cholangiocarcinoma, HER2 expressing gastric cancer, gastro-esophageal junction cancer or gastroesophageal junction adenocarcinoma and refractory HER2 low expressing metastatic breast cancer, HER2 positive and negative breast cancers, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, endometrial cancer, vulvar cancer, vaginal cancer, metastatic colorectal cancer, salivary gland tumor, head and neck squamous cell carcinoma, esophageal carcinoma, metastatic castration resistant prostate cancer (mCRPC), oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer and primary sarcoma of the gynecological reproductive system. It is a recombinant humanized anti-HER2 monoclonal antibody-monomethyl auristatin E (MMAE) antibody-drug conjugate administered through intravenous and intravenous drip routes in the form of powder for solution. The drug candidate acts by targeting the human epidermal growth factor receptor 2 (Her2). The drug candidate is developed based on antibody-drug conjugates technology. It was also under development for the treatment of ovarian cancer and bladder 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 – Disitamab Vedotin LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Disitamab Vedotin
Administration Pathway
· Intravenous| Intravenous Drip
Therapeutic Areas
· Oncology
Key Manufacturers
· Seagen 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.

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 – Disitamab Vedotin in Kidney Cancer (Renal Cell Cancer)
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