10.6084/m9.figshare.8317130.v1 Anthony Markham Anthony Markham Alpelisib: First Global Approval Adis Journals 2019 Alpelisib Adis Insight Report Adis Drug Evaluatoin Breast Cancer 2019-07-03 03:42:42 Online resource https://adisjournals.figshare.com/articles/online_resource/Alpelisib_First_Global_Approval/8317130 <div>Compliance with Ethical Standards</div><div><br></div><div><i>Disclosure</i> The preparation of this review was not supported by any external funding.</div><div><br></div><div><i>Conflicts of interest </i> A. Markham, a contracted employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.</div><div><br></div><div>Additional information about this Adis Insight Report can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a><br></div><div><br></div><div>Abstract</div><div><br></div><div>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.<br></div><div><div><br></div><div>© Springer Nature Switzerland AG 2019</div></div><div><br></div>