Alpelisib - Novartis Oncology

Drug Profile

Alpelisib - Novartis Oncology

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

Latest Information Update: 15 Jan 2018

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At a glance

  • Originator Novartis
  • Developer Columbia University; H. Lee Moffitt Cancer Center and Research Institute; Memorial Sloan-Kettering Cancer Center; Northwestern University; Novartis; Novartis Oncology; Peter MacCallum Cancer Centre; University Health Network
  • Class Amides; Antineoplastics; Dicarboxylic acids; 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.

  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 08 Jan 2018 UNICANCER plans the phase II SAFIR PI3K trial for Breast cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in February 2018 (NCT03386162)
  • 05 Dec 2017 Adverse events and efficacy data from the phase Ib portion of a phase Ib/II trial in Breast cancer presented at the 40th Annual San Antonio Breast Cancer Symposium (SABCS-2017)
  • 08 Nov 2017 Novartis withdraws a phase I/II trial prior to enrolment for Squamous cell cancer (Combination-therapy, Late-stage disease, Metastatic disease) in USA (PO) (NCT02298595)
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