VERZENIO
Verzenio (abemaciclib) is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. It is used as an adjuvant treatment for early breast cancer at high risk of recurrence and for the treatment of advanced or metastatic disease. Depending on the specific indication, the drug is administered as a monotherapy or in combination with endocrine therapies such as tamoxifen, fulvestrant, or aromatase inhibitors.
How VERZENIO Works
Abemaciclib functions by inhibiting cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), which are enzymes that drive cell cycle progression. In certain breast cancer cells, these kinases promote the phosphorylation of the retinoblastoma protein, leading to cell proliferation. By blocking this activity, abemaciclib prevents cells from advancing from the G1 phase into the S phase of the cell cycle. This inhibition triggers cellular senescence and apoptosis, effectively reducing tumor size and growth.
Details
- Status
- Prescription
- First Approved
- 2017-09-28
- Routes
- ORAL
- Dosage Forms
- TABLET
VERZENIO Approval History
What VERZENIO Treats
4 indicationsVERZENIO is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting
VERZENIO Competitors
Pro3 other drugs also target CDK4. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CDK4). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VERZENIO FDA Label Details
ProIndications & Usage
FDA Label (PDF)VERZENIO ® is a kinase inhibitor indicated: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. in combination with fulvestrant...
VERZENIO Patents & Exclusivity
Patents (68 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.