Likelihood of Approval and Phase Transition Success Rate Model – Trastuzumab Deruxtecan in Leptomeningeal Disease (Neoplastic Meningitis, Leptomeningeal Carcinomatosis)
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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.
Trastuzumab Deruxtecan in Leptomeningeal Disease (Neoplastic Meningitis, Leptomeningeal Carcinomatosis) Drug Details:
Trastuzumab deruxtecan (Enhertu, Detrastuzumab) composed of a protease-cleavable maleimide tetrapeptide and topoisomerase which is an exatecan derivative, produced in Chinese hamster ovary cells by recombinant DNA technology, that acts as an anti neoplastic agent. It is formulated as powder for solution for intravenous route of administration. Enhertu is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting and also for treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Enhertu is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy. Enhertu is indicated for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Trastuzumab deruxtecan (DS-8201) is under development for the treatment of osteosarcoma, gallbladder cancer, leptomeningeal carcinoma, refractory solid tumors including, metastatic or recurrent uterine carcinosarcoma, gastric cancer, non-squamous non-small cell lung cancer, metastatic biliary tract cancer, cervical cancer, endometrial cancer, epithelial ovarian cancer, metastatic pancreatic cancer, metastatic colorectal cancer, salivary gland cancer, Paget’s disease, cholangiocarcinoma, esophageal cancer, gastroesophageal junction adenocarcinoma, metastatic colorectal cancer, urothelial cancer, HR positive, HER2 low expressing and triple-negative breast cancer. The drug candidate is administered through intravenous route as a solution. The drug candidate is comprised of a humanized anti-HER2 antibody attached by a peptide linker to a derivative of the camptothecin analog exatecan and DNA topoisomerase 1 inhibitor (DXd) as payload. It is developed based on proprietary payload and linker-payload technology. It acts by targeting human epidermal growth factor receptor 2 (Her-2). It was also under development for osteosarcoma.
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.
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Reasons to Buy
- Precise Likelihood of Approval and Phase Transition Success Rates: Our machine learning and proprietary models provide accurate predictions, helping you gauge the potential success of a drug in the regulatory process.
- Competitive Strategy Planning: Access information on LOA and PTSR for competitors’ drugs, allowing you to plan your clinical development, commercialisation and marketing strategies
- Event-driven Updates: Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR. Get the latest insights to adapt your strategies promptly!
- Well-informed Investment Decisions: This data helps you navigate the dynamic landscape of drug development and regulatory considerations.
Scope
- Drug Details: Drug name, Drug type, Intervention type
- Administration Pathway
- Therapeutic Areas
- Key Manufacturers
- Drug Development Status
This is an on-demand report that will be delivered upon request. The report will be delivered within 2 business days of the purchase, excluding weekends and holidays. Certain sections of the report may be removed or altered based on data availability and relevance.
Frequently asked questions
- 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
- Phase I, Phase II, Phase III, and Pre-Registration development stage
- 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”
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- 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.
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:
Drug Phase Scope:
Drug Geography Scope:
Drug Type Scope:
Entity Type Scope:
Only drugs in development by companies are included in the model.
Exclusion
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