Likelihood of Approval and Phase Transition Success Rate Model – Alpelisib in Metastatic Breast Cancer
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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.


Alpelisib in Metastatic Breast Cancer Drug Details:
Alpelisib (Piqray, Pivikto, Trezilent) is a proline or derivative acts as an antineoplastic agent. It is formulated as film coated tablets for oral route of administration. Alpelisib is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive and HER2 negative, PIK3CA mutated, advanced or metastatic breast cancer.Alpelisib (BYL-719) is under development for the treatment of metastatic breast cancer, HER2 negative metastatic breast cancer, endometrial cancer, PIK3CA-related overgrowth spectrum disorder, ovarian cancer, fallopian tube cancer, peritoneal cancer, HPV+ squamous cell carcinoma, lymphatic malformations or PIK3CA-related overgrowth spectrum (PROS). The drug candidate is administered through oral route and targets phosphatidylinositol 3-kinase (PI3K) alpha.It was also under development for skin rash in patients with metastatic breast cancer, epithelial ovarian cancer, metastatic uveal melanoma, recurrent or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma (ESCC), HPV-associated oropharyngeal squamous cell carcinoma, ovarian carcinoma, gastroesophageal (GE) junction carcinomas, gastrointestinal stromal tumor, non-small cell lung cancer, advanced or metastatic pancreatic cancer, renal cell carcinoma, pancreatic neuroendocrine tumors (pNETs), metastatic colorectal cancer, acute myelocytic leukemia (AML), metastatic gastric cancer, triple negative breast cancer, advanced HER2+breast cancer, and relapsed or refractory multiple myeloma, myelodysplastic syndrome.
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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