FDA Approves Faslodex in Combo with Verzenio for Women with Advanced Breast Cancer

FDA Approves Faslodex in Combo with Verzenio for Women with Advanced Breast Cancer
The U.S. Food and Drug Administration (FDA) expanded to use of AstraZeneca’s Faslodex (fulvestrant) to include it in combination with Verzenio (abemaciclib) to treat HR-positive, HER2-negative advanced or metastatic breast cancer in women whose disease progressed after hormonal therapy. The approval is the result of data demonstrating that combined therapy improved progression-free patient survival by 7.1 months, compared to those receiving Faslodex alone. “Faslodex has long been an effective monotherapy option for women with hormone receptor-positive breast cancer, which is the most common type of advanced breast cancer,” Dave Fredrickson, executive vice president, head of the Oncology Business Unit at AstraZeneca, said in a press release. “Today’s decision builds upon the recent approval for Faslodex in the first-line advanced setting and is supported by strong evidence to use this medicine within a combination therapy for advanced breast cancer. Combining Faslodex with abemaciclib provides patients with another effective, non-chemotherapy option to combat this disease.” Verzenio, developed by Eli Lilly, is a drug blocking the CDK4/6 enzyme. The combination was studied in the Phase 3 MONARCH 2 study (NCT02107703) that incl
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