Verzenio Approved for Breast Cancer
September 28, 2017 – The U.S. FDA has approved Verzenio™ (abemaciclib), manufactured by Eli Lilly, for use in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. Verzenio also received approval as a monotherapy for 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 works by inhibiting enzymes that contribute to the growth and spread of cancer in the body. It specifically targets cyclin-dependent kinases 4 and 6 (CDK4/6). Recommended dosing is 150mg twice per day to start if used in combination with fulvestrant. When used as a monotherapy, Verzenio has a recommended starting dose of 200mg twice per day. It is available as 50mg, 100mg, 150mg, and 200mg tablets.
In a clinical study, patients who were taking Verzenio plus fulvestrant experienced average progression-free survival rates approximately seven months longer than those who took fulvestrant alone. Serious side effects associated with the use of Verzenio include diarrhea, low white blood cell count, elevated liver enzymes, and blood clots.
The American Cancer Society estimates that, each year in the U.S., 250,000 cases of invasive breast cancer are diagnosed. Of those patients currently living with breast cancer, approximately 150,000 have metastatic disease. Verzenio is the third CDK4/6 inhibitor to be approved for treatment of breast cancer in the U.S., after Pfizer’s Ibrance® (palbociclib) and Novartis’ Kisqali® (ribociclib). Its estimated annual cost is $131,400.
Eli Lilly has already launched the product.
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