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Verzenio ® (abemaciclib) tablets
50mg, 100mg, 150mg, 200mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Is Verzenio® (abemaciclib) FDA approved?
Abemaciclib has been approved in combination with ET for the adjuvant treatment of adult patients with HR+, HER2-, node-positive EBC and in treatment of HR+/HER2− advanced or MBC in combination with an NSAI, fulvestrant, or as monotherapy.
Is abemaciclib FDA approved?
Early Breast Cancer
On October 12, 2021, the Food and Drug Administration (FDA) approved VERZENIO® (abemaciclib) for use
- in combination with endocrine therapy (ET) (tamoxifen or an aromatase inhibitor [AI]) for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive early breast cancer (EBC) at high risk of recurrence and a Ki-67 score ≥20% as determined by an FDA approved test.1
On March 3, 2023, the FDA updated previously approved indications for VERZENIO® (abemaciclib) as follows
- in combination with ET (tamoxifen or an AI) for the adjuvant treatment of adult patients with HR+, HER2-, node-positive EBC at high risk of recurrence.1
Advanced or Metastatic Breast Cancer
On September 28, 2017, the FDA approved VERZENIO® (abemaciclib) for use
- in combination with fulvestrant for the treatment of women with HR+, HER2- advanced or metastatic breast cancer (MBC) with disease progression following ET, and
- as monotherapy for the treatment of adult patients with HR+, HER2- advanced or MBC with disease progression following ET and prior chemotherapy in the metastatic setting.1
On February 26, 2018, the FDA approved abemaciclib for use
- in combination with an AI as initial endocrine-based therapy for the treatment of postmenopausal women with HR+, HER2- advanced or MBC.1
On October 12, 2021, the FDA updated previously approved indications for VERZENIO® (abemaciclib) as follows
- in combination with an AI as initial endocrine-based therapy for the treatment of postmenopausal women, and men, with HR+, HER2- advanced or MBC, and
- in combination with fulvestrant for the treatment of adult patients with HR+, HER2- advanced or MBC with disease progression following ET.1
On March 3, 2023, the FDA updated previously approved indications for VERZENIO® (abemaciclib) as follows
- in combination with an AI as initial endocrine-based therapy for the treatment of adult patients with HR+, HER2- advanced or MBC.1
Enclosed Prescribing Information
Enclosed Patient Information
Reference
1Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
Date of Last Review: February 20, 2023