Abemaciclib: First Global Approval

Funding: The preparation of this review was not supported by any external funding.

Conflicts of interest: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Esther Kim is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found at here.

Abstract

Abemaciclib (Verzenio™) is an orally administered inhibitor of cyclin-dependent kinases 4 and 6 that is being developed by Eli Lilly and Company. Abemaciclib has been approved in the USA for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant in women with disease progression following endocrine therapy, and as monotherapy in adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. In addition, abemaciclib is in various stages of development internationally for HR-positive breast cancer, non-small lung cancer and a variety of other cancers. This article summarizes the milestones in the development of abemaciclib leading to this first approval for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer. Access to the full article can be found here.

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