Expanded Indication for Faslodex
November 15, 2017 – The U.S. FDA has approved an expanded indication for Faslodex® (fulvestrant), manufactured by AstraZeneca. Faslodex may now be used in combination with Verzenio™ (abemaciclib), manufactured by Eli Lilly, to treat women who have advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has worsened after treatment with an endocrine drug, such as tamoxifen or anastrozole.
Faslodex acts as an estrogen-receptor antagonist, which helps to block hormones that can contribute to the growth and spread of hormone receptor-positive breast cancers. Verzenio, a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, helps to block enzymes that contribute to the growth and spread of cancer cells. When used together, Faslodex and Verzenio improved the average progression-free survival rate by approximately seven months compared to using Faslodex alone.
Recommended dosing with the combination includes one 150mg oral tablet of Verzenio taken twice daily, and a 28-day dosing cycle for Faslodex, which is delivered via intramuscular (IM) injection. During the first cycle, Faslodex should be given as a 500mg IM injection on the first and fifteenth days. In subsequent cycles, it should be given on the first day only, again as a 500mg IM injection. Faslodex dosage should be adjusted for patients who have hepatic impairment.
Although Verzenio was first granted approval in September of 2017, Faslodex was first approved in 2002 as a treatment for breast cancer in women.
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