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

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

Published: November 03, 2023 Report Code: GDHCDR10214LOA-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.


Regorafenib in Ewing Sarcoma Drug Details:

Regorafenib (BAY 73-4506, Stivarga) is an anti-neoplastic agent. Regorafenib is formulated as film coated tablets and tablets for oral route of administration. It is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, an anti-VEGF therapy, and if RAS wild-type, an anti-EGFR therapy, for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.Regorafenib is under development for the treatment of recurrent glioblastoma multiforme, gliosarcoma, chordoma, metastatic biliary tract cancer, esophageal cancer, gastric cancer, metastatic colorectal cancer, gastrointestinal stromal tumor (GIST), metastatic hepatocellular carcinoma, glioblastoma multiforme,  oropharyngeal cancer, metastatic colorectal cancer following surgical removal of liver metastases, urothelial cancer, liposarcoma, osteosarcoma, Ewing sarcoma, chondrosarcoma,  rhabdomyosarcoma, advanced solid tumors cancers such as metastatic adenocarcinoma of the pancreas, hepatocellular carcinoma (as first line therapy),adenocarcinoma of the gastroesophageal junction, soft tissue sarcoma, biliary tract cancer (cholangiocarcinoma), extrahepatic cholangiocarcinoma,  adenoid cystic carcinoma (salivary gland cancer), acute myeloid leukemia, myelodysplastic syndrome and myelofibrosis, head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), pancreatic ductal adenocarcinoma (PDAC), biliary duct carcinoma (BTC), gastroesophageal (GE) junction carcinomas, glioblastoma multiforme (GBM) and anaplastic cell carcinoma (AA). It was under development for the treatment of renal cell carcinoma, recurrent epithelial ovarian, primary peritoneal, fallopian tube cancer, neovascular (wet) age-related macular degeneration as eye drops, colorectal cancer (adjuvant therapy), solid tumor in Japan and China and non-small cell lung cancer. It was also under development for the treatment of metastatic hepatocellular carcinoma and recurrent glioblastoma multiforme.

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 – Regorafenib LOA Data
Report Segments
· Drug type

· Intervention type
Drug Name
· Regorafenib
Administration Pathway
· Intravenous| Ophthalmic| Oral
Therapeutic Areas
· Oncology| Ophthalmology
Key Manufacturers
· Bayer AG
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 – Regorafenib in Ewing Sarcoma
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