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FDA approved Verzenio (abemaciclib) for Early and Advanced Breast CancerFDA approved Verzenio for early and advanced breast cancer.

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Key Takeaway
Consider Verzenio for HR+, HER2- breast cancer in adjuvant high-risk node-positive or advanced settings, with endocrine therapy or as monotherapy.

The FDA has approved Verzenio (abemaciclib) for two new indications in breast cancer. For early breast cancer, Verzenio is indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive disease at high risk of recurrence. For advanced or metastatic breast cancer, Verzenio is approved in combination with an aromatase inhibitor as initial endocrine-based therapy, in combination with fulvestrant after progression on endocrine therapy, and as monotherapy after progression on endocrine therapy and prior chemotherapy in the metastatic setting. This approval provides a new option for patients with high-risk early breast cancer and expands treatment choices for advanced disease.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Abemaciclib is a kinase inhibitor that inhibits cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), which are involved in cell cycle progression. It reduces phosphorylation of the retinoblastoma protein and blocks progression from G1 to S phase, leading to cell cycle arrest in tumor cells.

Indication & Patient Population

Verzenio is indicated for: - Adjuvant treatment of adult patients with HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence, in combination with endocrine therapy (tamoxifen or an aromatase inhibitor). - Initial endocrine-based therapy for HR-positive, HER2-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor. - Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy, in combination with fulvestrant. - Monotherapy for HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

Dosing & Administration

Recommended starting dose: 150 mg twice daily when used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor; 200 mg twice daily as monotherapy. Take orally with or without food. Swallow tablets whole; do not chew, crush, or split. If vomiting or missed dose, take next dose at scheduled time. For early breast cancer, continue for 2 years or until recurrence or unacceptable toxicity. For advanced/metastatic disease, continue until progression or unacceptable toxicity. Dose reductions and interruptions may be required for adverse reactions (see label for specific tables). Discontinue if unable to tolerate 50 mg twice daily.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Verzenio provides a CDK4/6 inhibitor option for both early and advanced HR-positive, HER2-negative breast cancer. In early disease, it is used as adjuvant therapy in high-risk node-positive patients. In advanced disease, it is a first-line option with an aromatase inhibitor, second-line with fulvestrant, or as monotherapy after multiple prior therapies.

The FDA has approved Verzenio (abemaciclib) for two new uses in breast cancer. First, it can be used in early breast cancer for patients with hormone receptor positive, HER2 negative disease that has spread to lymph nodes and has a high risk of coming back. In these patients, Verzenio is taken with hormone therapy like tamoxifen or an aromatase inhibitor. Second, for advanced or metastatic breast cancer, Verzenio can be used with an aromatase inhibitor as the first hormone based treatment, with fulvestrant after hormone therapy stops working, or alone after hormone therapy and chemotherapy have been tried.

This approval is important because it gives patients with high risk early breast cancer a new option to lower the chance of the cancer returning. For those with advanced disease, it adds to the choices available. Verzenio is a pill taken by mouth, and it works by blocking certain proteins that help cancer cells grow.

However, like all medicines, Verzenio has side effects. Common ones include diarrhea, low blood cell counts, and fatigue. Patients should talk to their doctor about whether Verzenio is right for them, especially if they have other health conditions or take other medications. This approval does not mean Verzenio is for everyone with breast cancer. It is only for specific types and stages.

The bottom line is that Verzenio offers a new tool for certain breast cancer patients. If you or a loved one has breast cancer, ask your doctor if Verzenio might be an option. Always follow your doctor's advice about your treatment plan.

What this means for you:
Verzenio is a new option for certain breast cancers; talk to your doctor if it might be right for you.

Study Details

Study typeFda approval
PublishedSep 2017
View Original Abstract ↓
1 INDICATIONS AND USAGE 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. ( 1.1 , 14.1 ) 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. ( 1.2 ) in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. ( 1.2 ) 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. ( 1.2 ) 1.1 Early Breast Cancer VERZENIO ® (abemaciclib) is 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 [see Clinical Studies ( 14.1 )]. 1.2 Advanced or Metastatic Breast Cancer VERZENIO (abemaciclib) is indicated: 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 for the treatment of adult patients 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.
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