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Abstract
Since the US FDA approval of everolimus/exemestane in July 2012, and of the first CDK 4/6 inhibitor, palbociclib, combined with endocrine treatment in February 2015, a third class of therapeutic compounds, the PI3K inhibitors, has been introduced to the arsenal of targeted therapies overcoming endocrine resistance in hormone receptor-positive metastatic breast cancer. Alpelisib (PIQRAY®) is the first of these novel agents yielding promising clinical results, giving an impetus to further development of tailored endocrine anticancer treatments. Herein, we review its pharmacodynamic and pharmacokinetic properties, safety and efficacy data, as well as Phase III SOLAR-1 trial, prompting FDA approval of alpelisib in hormone receptor-positive metastatic breast cancer harboring PIK3CA mutations. Furthermore, implications for clinical use and current research will also be discussed.
Author contributions
A Mavratzas and F Marmé designed the article, A Mavratzas performed literature research and wrote the manuscript. F Marmé reviewed the article. All the authors approved the final version.
Acknowledgments
The authors apologize to those researchers whose original research could not be mentioned due to a limited numbers of references.
Financial & competing interests disclosure
F Marmé received honoraria from Roche, Amgen, AstraZeneca, Eisai, Celgene, Novartis, Pfizer, Genomic Health and acted as a consultant to Roche, AstraZeneca and Novartis. A Mavratzas received travel sponsoring from Pfizer, Eisai and Celgene, as well as honoraria from Roche. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Company review disclosure
In addition to the peer-review process, with the authors’ consent, the manufacturer of the product discussed in this article was given the opportunity to review the manuscript for factual accuracy. Changes were made by the authors at their discretion and based on scientific or editorial merit only. The authors maintained full control over the manuscript, including content, wording and conclusions.