• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Verzenio (abemaciclib)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Verzenio (abemaciclib)

  • Profile

Profile

Contact Information

Contact: Eli Lilly
Website: https://www.lilly.com/

Currently Enrolling Trials

    Show More

    General Information

    Verzenio (abemaciclib) is a kinase inhibitor.

    Verzenio is specifically indicated for use:

    • In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
    • As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

     

    Mechanism of Action

    Verzenio (abemaciclib) is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases are activated upon binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression and cell proliferation. In vitro, continuous exposure to abemaciclib inhibited Rb phosphorylation and blocked progression from G1 into S phase of the cell cycle, resulting in senescence and apoptosis.

    Side Effects

    Adverse effects associated with the use of Verzenio may include, but are not limited to, the following:

    • Diarrhea
    • Neutropenia and leukopenia
    • Nausea
    • Abdominal pain
    • Infections
    • Fatigue
    • Anemia
    • Decreased appetite
    • Vomiting
    • Headache

    Dosing/Administration

    Verzenio is supplied as a tablet for oral administration. The recommended starting dose in combination with fulvestrant is 150 mg twice daily. The recommended starting dose as monotherapy is 200 mg twice daily. Continue treatment until disease progression or unacceptable toxicity. Dosing interruption and/or dose reductions may be required based on individual safety and tolerability. Please see drug label for specifications.

    Clinical Trial Results

    FDA Approval

    The FDA approval of Verzenio was based on two studies, MONARCH 1 and MONARCH 2.

    MONARCH 1: This phase 2 trial evaluated Verzenio as a monotherapy and enrolled 132 patients with HR+/HER2- metastatic breast cancer where endocrine therapy was no longer a viable option. In the study, 19.7 percent of patients taking Verzenio experienced complete or partial shrinkage of their tumors for a median 8.6 months.

    MONARCH 2: This phase 3 study evaluated Verzenio in combination with Faslodex and enrolled 669 patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer randomized into two different dosing arms: 1) Verzenio in combination with Faslodex or 2) Faslodex with a placebo. The primary end point of this study was progression-free survival (PFS). Verzenio and Faslodex improved PFS compared to the Faslodex plus placebo arm, (16.4 months versus 9.3 months; p < .0000001). 

     

     

     

    Approval Date: 2017-09-01
    Company Name: Eli Lilly
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • SurveywBlueBackground-360x240.png

      Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

    • TrendsInsights2023-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Two

    • TimeMoneyEffort-360x240.png

      Time is Money and So Is Effort, Budgeting Experts Say

    • TrendsInsights2023A-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Three

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing