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Alpelisib - Novartis Oncology

Drug Profile

Alpelisib - Novartis Oncology

Alternative Names: BYL-719; NVP-BYL-719; Piqray

Latest Information Update: 06 Jan 2020

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At a glance

  • Originator Novartis
  • Developer Columbia University; H. Lee Moffitt Cancer Center and Research Institute; Novartis; Novartis Oncology; University Health Network
  • Class Amides; Antineoplastics; Fluorine compounds; Pyridines; Pyrrolidines; Small molecules; Thiazoles
  • Mechanism of Action Phosphatidylinositol 3 kinase alpha inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Growth disorders
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Breast cancer
  • Phase III Head and neck cancer; Ovarian cancer
  • Discontinued Gastric cancer; Gastrointestinal stromal tumours; Multiple myeloma; Non-small cell lung cancer; Oesophageal cancer; Pancreatic cancer; Rectal cancer; Solid tumours; Uveal melanoma

Most Recent Events

  • 23 Dec 2019 Novartis plans a phase III trial for Breast cancer (Combination therapy, Second-line therapy or greater, Late-stage disease) (NCT04208178)
  • 05 Dec 2019 Alpelisib - Novartis Oncology receives Breakthrough Therapy status for PIK3CA-relative overgrowth syndrome (Growth disorders) in USA
  • 05 Dec 2019 Alpelisib - Novartis Oncology receives Orphan Drug status for PIK3CA-relative overgrowth syndrome (Growth disorders) in USA
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