Verzenio ® (abemaciclib) tablets

50mg, 100mg, 150mg, 200mg

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Verzenio® (abemaciclib): FDA Approval and Indication

Abemaciclib has been approved for treatment of HR+/HER2− advanced or metastatic breast cancer in combination with an NSAI, fulvestrant, or as monotherapy.

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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

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


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