Alpelisib is under clinical development by Novartis and currently in Phase III for Mutational Disorders. According to GlobalData, Phase III drugs for Mutational Disorders have a 43% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Alpelisib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Alpelisib overview

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 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.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. Novartis conducts research in various disease areas through the BioMedical Research division. The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

For a complete picture of Alpelisib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.