Abemaciclib With Endocrine Therapy Receives Expanded Approval for Early Breast Cancer

The FDA has granted approval to abemaciclib (Verzenio®, Eli Lilly and Company) with endocrine therapy—tamoxifen or an aromatase inhibitor—for treatment of adult patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-positive early breast cancer that is at a high risk of recurrence. Patients considered at high risk for recurrence include those with four or more pathologic axillary lymph nodes (pALN) or one to three pALN plus either a grade 3 t...

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Abemaciclib Plus Endocrine Therapy Approved for Early Breast Cancer

The FDA has approved abemaciclib (Verzenio®, Eli Lilly and Company) in combination with endocrine therapy consisting of an aromatase inhibitor or tamoxifen as adjuvant therapy for patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-positive early breast cancer with a high risk of recurrence. Abemaciclib, the first CDK4/6 inhibitor to be approved in the adjuvant breast cancer setting, is indicated for patients with a Ki-67 score of ≥20%. In...

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Advanced Breast Cancer: Adding Abemaciclib to Fulvestrant Improves Survival

​Updated results from MONARCH 2 report that adding abemaciclib (Verzenio®, Eli Lilly) to fulvestrant (Faslodex®, AstraZeneca) improves overall survival compared with fulvestrant alone in patients with endocrine-refractory hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. "Most patients with metastatic breast cancer have tumors that are HR-positive and are initially treated with endocrine therapy. Although endocrine therapy is an effi...

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