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Verzenio Approval History

FDA Approved: Yes (First approved September 28, 2017)
Brand name: Verzenio
Generic name: abemaciclib
Dosage form: Tablets
Company: Eli Lilly and Company
Treatment for: Breast Cancer

Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Development History and FDA Approval Process for Verzenio

Feb 26, 2018Approval Lilly Receives Additional FDA Approval for Verzenio (abemaciclib), as Initial Treatment for Advanced Breast Cancer
Sep 28, 2017Approval FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers
Jul 12, 2017FDA Grants Priority Review for Lilly's Abemaciclib for the Treatment of Advanced Breast Cancer
Jun  3, 2017Lilly Builds Upon Body Of Data For Abemaciclib With Phase 3 MONARCH 2 Data Demonstrating Superior Progression-Free Survival In Advanced Breast Cancer
Apr 24, 2017Lilly Announces Phase 3 MONARCH 3 Breast Cancer Study Of Abemaciclib Demonstrated Superior Progression-Free Survival At Interim Analysis
Mar 20, 2017Lilly Announces Phase 3 MONARCH 2 Breast Cancer Study Of Abemaciclib Met Primary Endpoint Of Progression-Free Survival
Dec  8, 2016Lilly Presents NeoMONARCH Phase 2 Data On Abemaciclib In Early-Stage Breast Cancer
Aug 10, 2016Lilly Provides Update On MONARCH 2 Phase 3 Trial Of Abemaciclib
Jun  3, 2016Lilly Announces Results From MONARCH 1 Trial Of Abemaciclib Monotherapy
Oct  8, 2015Lilly Receives FDA Breakthrough Therapy Designation For Abemaciclib - A CDK 4 And 6 Inhibitor - In Advanced Breast Cancer

Further information

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