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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.
Verzenio® (abemaciclib): FDA Approval and Indication
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.
Detailed Information
Early Breast Cancer
On October 12, 2021, the FDA approved VERZENIO® (abemaciclib) for use
- 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 and a Ki-67 score ≥20% as determined by an FDA approved test.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 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.
- in combination with fulvestrant for the treatment of adult patients with HR+, HER2- advanced or MBC with disease progression following ET.1
Enclosed Prescribing Information
Enclosed Patient Information
Reference
1Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.
Glossary
AI = aromatase inhibitor
EBC = early breast cancer
ET = endocrine therapy
FDA = Food and Drug Administration
HER2- = human epidermal growth factor receptor 2-negative
HR+ = hormone receptor-positive
MBC = metastatic breast cancer
NSAI = nonsteroidal aromatase inhibitor
Date of Last Review: October 11, 2021