Indications of Abemaciclib

1. Early Breast Cancer

Abemaciclib® (VERZENIO, abemaciclib) is indicated for the following:In combination with endocrine therapy (tamoxifen or aromatase inhibitors), for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.

2. Advanced or Metastatic Breast Cancer

Abemaciclib (VERZENIO, abemaciclib) is indicated for the following:

In combination with aromatase inhibitors, as initial endocrine therapy, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

In combination with fulvestrant, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer whose disease has progressed following endocrine therapy.

As monotherapy, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer whose disease has progressed following endocrine therapy and who have received chemotherapy in the metastatic setting.

FDA，2025.02