What is Verzenio (abemaciclib) used for?

What is Verzenio (Abemaciclib) Used For?

Verzenio (abemaciclib) is a CDK4/6 inhibitor approved for treating hormone receptor-positive, HER2-negative breast cancer in both early-stage high-risk disease and advanced/metastatic settings. 1

FDA-Approved Indications

Early Breast Cancer

• Adjuvant treatment in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adult patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence 1
• Treatment continues for 2 years or until disease recurrence or unacceptable toxicity 1

Advanced or Metastatic Breast Cancer

Verzenio has three distinct FDA-approved uses in the metastatic setting:

First-line therapy:

• In combination with an aromatase inhibitor as initial endocrine-based therapy for HR-positive, HER2-negative advanced or metastatic breast cancer 1
• The recommended dose is 150 mg orally twice daily when combined with endocrine therapy 1

Second-line therapy:

• In combination with fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy 1
• This is a Category 1 (highest level) recommendation from NCCN guidelines 2

Monotherapy:

• As single-agent treatment for HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy AND prior chemotherapy in the metastatic setting 1
• The recommended monotherapy dose is 200 mg orally twice daily 1
• In the MONARCH 1 trial, single-agent abemaciclib achieved a 19.7% objective response rate and median overall survival of 22.3 months in heavily pretreated patients (average of 3 prior systemic regimens) 2

Clinical Evidence Supporting Use

First-Line Combination Therapy

• The MONARCH 3 trial demonstrated that abemaciclib plus an aromatase inhibitor improved median progression-free survival to 28.18 months versus 14.76 months with aromatase inhibitor alone (HR 0.54) 2
• Objective response rate was significantly higher with the combination (59% vs 44%) 2

Second-Line Combination Therapy

• The MONARCH 2 trial showed abemaciclib plus fulvestrant improved median progression-free survival to 16.4 months versus 9.3 months with fulvestrant alone (HR 0.553) 2
• Median overall survival was significantly improved: 46.7 months versus 37.3 months (HR 0.757) 2
• The benefit was particularly strong in patients with visceral disease and those with primary endocrine resistance 2

Special Populations

Premenopausal and perimenopausal women:

• Must receive concurrent gonadotropin-releasing hormone (GnRH) agonist when Verzenio is combined with an aromatase inhibitor or fulvestrant 1

Men with breast cancer:

• Should receive GnRH agonist when Verzenio is combined with an aromatase inhibitor 1

Key Safety Considerations

Most common adverse events:

• Diarrhea (most frequent, occurring in 81-90% of patients) 2
• Neutropenia (grade 3-4 in 21-27% of patients) 2
• Fatigue, nausea, and decreased appetite 2

Critical management points:

• Diarrhea can be effectively managed with dose modifications and antidiarrheal medications in 83.8% of cases 2
• Blood counts should be monitored on day 14 of the first two cycles and at the start of each 28-day cycle 2
• Dose reductions are available (150 mg → 100 mg → 50 mg twice daily for combination therapy) 1