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Review
. 2019 Jul;79(11):1249-1253.
doi: 10.1007/s40265-019-01161-6.

Alpelisib: First Global Approval

Anthony Markham  1
Affiliations
Review

Alpelisib: First Global Approval

Anthony Markham. Drugs. 2019 Jul.

Abstract

Alpelisib (Piqray™)-an orally available phosphatidylinositol 3-kinase (PI3K) inhibitor with specific activity against PI3K alpha (PI3Kα)-is being developed by Novartis for the treatment of breast cancer. Alpelisib has demonstrated efficacy in combination with fulvestrant as treatment for hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER2)-negative breast cancer in patients with a PIK3CA mutation and was recently approved for this indication in the USA. This article summarizes the milestones in the development of alpelisib leading to this first approval.

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