Likelihood of Approval and Phase Transition Success Rate Model – Enfortumab Vedotin in Solid Tumor
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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.


Enfortumab Vedotin in Solid Tumor Drug Details:
Enfortumab vedotin (Padcev) acts an anti-neoplastic agent. It is formulated as powder for solution for intravenous route of administration. Padcev is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting and also indicated in patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Padcev is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor.Enfortumab vedotin (AGS-22, AGS-22CE, AGS-22ME, AGS-22M6E) is under development for the treatment of solid tumors including metastatic castration-resistant prostate cancer, advanced or metastatic colorectal cancer (CRC) or hepatocellular carcinoma (HCC), advanced or metastatic urothelial carcinoma (mUC), urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC), bladder carcinoma, ureter cancer, urethral cancer, non-muscle invasive bladder cancer, gastric cancer, head and neck squamous cell carcinoma, non-squamous non-small cell lung cancer, squamous non-small cell lung cancer, triple negative breast cancer, gastroesophageal junction (GEJ) cancer, esophageal cancer, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, bladder cancer, renal pelvis, HR positive human epidermal growth factor receptor 2 negative breast cancer, ureter, ER positive human epidermal growth factor receptor 2 negative breast cancer, urethra cancer. The therapeutic candidate is administered as an intravenous and intravesical infusion. It is an antibody-drug conjugate (ADC) that acts by targeting nectin-4.
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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