Skip To Main Content
Lilly
Menu closed
Lilly
  • Account Login / Register
  • Medical Home
    • Medical Information
  • Medical Education
  • Science
Ask Lilly

We're here to help.

Chat
Chat with us Chat with us
Question Contact Us
Expand contact lilly
Lilly

You are now leaving the LillyMedical.com website

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to LillyMedical.com.

  1. Medical Information Right
  2. Oncology Right
  3. Verzenio (abemaciclib) tablets Right
  4. Is Verzenio® (abemaciclib) FDA approved?
Search Verzenio (type in keywords)
Search Medical Information

If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)

Loading icon

Verzenio ® (abemaciclib) tablets

50mg, 100mg, 150mg, 200mg

Full Prescribing Information

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.

US_cFAQ_ABE017_FDA_APPROVAL
US_cFAQ_ABE017_FDA_APPROVAL
en-US

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

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

Enclosed Patient Information

VERZENIO® (abemaciclib) patient information, Lilly

Reference

1Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.

Date of Last Review: February 20, 2023

Are you satisfied with this content?

Can't find what you're looking for? Contact us for answers to your medical questions.

  • Copyright
  • Terms of Use
  • Privacy Statement
  • Accessibility Statement
  • Sitemap

    This site is intended for US Healthcare Professionals only.

    4.0.17 02/2023 | GLOOTH00001 04/2015 | © Lilly USA, LLC 2023. All rights reserved.

    Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates

    facebook twitter linkedin
    visit www.phactmi.org
    Lilly