Verzenio FDA Approval History
Last updated by Judith Stewart, BPharm on March 19, 2023.
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 used for the treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2 negative (HR+ HER2-) metastatic breast cancer.
- Approximately 70 percent of all breast cancers are of the HR+ HER2- subtype.
- Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells.
- Verzenio 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.
- 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.
- Verzenio tablets are usually taken orally twice daily with or without food.
- Verzenio can cause serious adverse reactions including severe diarrhea, neutropenia, interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, and venous thromboembolism.
- Common adverse reactions include diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia.
Development timeline for Verzenio
Further information
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