10/04/2017

The FDA has approved Verzenio™ (abemaciclib) in combination with fulvestrant for certain types of breast cancer

The FDA has approved Verzenio™ (abemaciclib) in combination with fulvestrant for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer with disease progression following endocrine therapy, and as monotherapy for the treatment of adult patients with HR+, HER2− advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. It is the first and only CDK4 & 6 inhibitor FDA approved in combination with fulvestrant and as monotherapy.

Verzenio is a cyclin-dependent kinase (CDK)4 & 6 inhibitor that will be available as 50, 100, 150 and 200 mg tablets. The recommended dose of Verzenio, in combination with fulvestrant, is 150 mg orally twice daily. As a monotherapy, the recommended dose of Verzenio is 200 mg orally twice daily. Both doses are recommended to be continued until disease progression or unacceptable toxicity occurs.

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