Likelihood of Approval and Phase Transition Success Rate Model – Donafenib Tosylate in Head And Neck Squamous Cell Carcinoma (HNSC)
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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.


Donafenib Tosylate in Head And Neck Squamous Cell Carcinoma (HNSC) Drug Details:
Donafenib tosylate (Zepsun) is a deuterated sorafenib derivative. It is formulated as tablets for oral route of administration. Zepsun is indicated to treat patients with unresectable advanced hepatocellular carcinoma who have not received systemic treatment in the past.Donafenib is under development for the treatment of solid tumors, endometrial cancer, advanced metastatic head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma, esophageal cancer, colorectal cancer, pancreatic cancer and cholangiocarcinoma. It is administered orally in the form of tablet. The drug candidate is a multikinase inhibitor of multiple receptor kinases. It was also under development for refractory differentiated thyroid cancer includes papillary thyroid cancer, follicular, hurthle cell thyroid cancers, esophageal cancer, acute myelocytic leukemia.It was also under development for the treatment of relapsed acute myeloid leukemia and metastatic gastric cancer, metastatic nasopharyngeal carcinoma and recurrent head and neck squamous cell carcinoma (HNSCC).As of 2021, Donafenib as monotherapy discontinued development for metastatic colorectal 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.
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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
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