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

Detailed Information

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

Enclosed Prescribing Information

VERZENIO® (abemaciclib) tablets, for oral use, Lilly

Enclosed Patient Information

VERZENIO® (abemaciclib) patient information, Lilly

Reference

1. Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

Glossary

AI = aromatase inhibitor

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: January 02, 2019

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