Likelihood of Approval and Phase Transition Success Rate Model – Ramucirumab in Metastatic Adenocarcinoma of The Pancreas

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lgp loa report cover Likelihood of Approval and Phase Transition Success Rate Model – Ramucirumab in Metastatic Adenocarcinoma of The Pancreas

Published: November 03, 2023 Report Code: GDHCDR17895LOA-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.


Ramucirumab in Metastatic Adenocarcinoma of The Pancreas Drug Details:

Ramucirumab (Cyramza) is an antineoplastic agent. It is formulated as injection solution, concentrate solution for intravenous route o administration. Cyramza as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced  or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine-or platinum-containing chemotherapy, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy, in combination with FOLFIRI (irinotecan, folinic acid, and 5 -fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine, and as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of =400 ng/mL and have been previously treated with sorafenib. Cyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations.The drug candidate is under development for the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT), hepatocellular carcinoma, malignant mesothelioma, pancreatic adenocarcinoma, adenocarcinoma of the gastroesophageal junction, bladder cancer, urethral cancer, non-small cell lung carcinoma, squamous non-small cell lung cancer, metastatic colorectal cancer, progressive carcinoid tumors, squamous cell carcinoma of the esophagus, pancreatic neuroendocrine tumor, gallbladder cancer, small-cell lung cancer and metastatic biliary tract cancer, metastatic thymic carcinoma, gastroesophageal junction region (GEJ) cancer, pediatric solid tumors including CNS, non-CNS tumors. The drug candidate was also under development for the treatment of refractory/relapsed synovial sarcoma, HER2 negative metastatic breast cancer and gastric cancer as first-line therapy, fallopian tube cancer, peritoneal tumor, epithelial ovarian cancer, metastatic hormone refractory (castration-resistant, androgen-independent) prostate cancer, metastatic melanoma, bladder cancer, metastatic transitional cell cancer (urothelial cell cancer) including bladder cancer, urethral cancer, ureter cancer, recurrent glioblastoma multiforme (GBM), mantle cell lymphoma,  HER2 positive metastatic breast cancer as second-line therapy, metastatic renal cell carcinoma, signet ring cell squamous cell carcinoma, recurrent head and neck squamous cell carcinoma, oral cavity cancer, oropharyngeal cancer, laryngeal cancer and hypopharyngeal cancer. It is administered through subcutaneous route.

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 – Ramucirumab LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Ramucirumab
Administration Pathway
· Intravenous| Subcutaneous
Therapeutic Areas
· 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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