Likelihood of Approval and Phase Transition Success Rate Model – Retifanlimab in Transitional Cell Carcinoma (Urothelial Cell Carcinoma)
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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.


Retifanlimab in Transitional Cell Carcinoma (Urothelial Cell Carcinoma) Drug Details:
Retifanlimab (Zynyz) is a humanized IgG4 kappa monoclonal antibody produced in Chinese hamster ovary cells. It is formulated as solution for intravenous route of administration. Zynyz is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.Retifanlimab (MGA-012) is under development for the treatment of solid tumors including retroperitoneal sarcoma, newly-diagnosed glioblastoma multiforme, muscle-invasive urothelial carcinoma, well differentiated liposarcoma and dedifferentiated liposarcoma, advanced penile squamous cell carcinoma, recurrent and metastatic squamous cell carcinoma of the head and neck including oropharyngeal cancer, oral cavity cancer, hypopharynx cancer, and laryngeal cancer, metastatic melanoma, anal cancer, recurrent glioblastoma multiforme, metastatic non-small cell lung cancer, relapsed or refractory acute myeloid leukemia, metastatic urothelial cancer, metastatic renal cell carcinoma, cervical cancer, metastatic adenosquamous carcinoma of the pancreas, endometrial cancer, HER2 positive gastric cancer, gastroesophageal junction adenocarcinoma and soft tissue sarcoma. The therapeutic candidate is administered as an intravenous infusion. It is a monospecific, bivalent and it’s half life last from days to weeks. It is based on Fc Optimization platform technology. The therapeutic candidate acts by targeting Programmed Cell Death Protein 1. It was also under development for hematological malignancies, squamous carcinoma of the anal canal, esophageal squamous cell carcinoma and merkel cell carcinoma.It was also under development for the treatment of metastatic triple negative breast 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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