The US Food and Drug Administration (FDA) has approved an expanded indication for AstraZeneca’s Faslodex (fulvestrant) in combination with Verzenio / abemaciclib, a CDK4/6 inhibitor, to treat advanced breast cancer.
Faslodex has been approved for use in treating women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) with disease progression after endocrine therapy.
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The drug is indicated for the treatment of oestrogen receptor-positive, locally advanced or MBC in post-menopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-oestrogen therapy.
AstraZeneca Oncology Business Unit executive vice-president and head Dave Fredrickson said: “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.
“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.”
The approval is based on data obtained from the international, randomised, double-blind, placebo-controlled, multicentre, Phase III Monarch 2 trial.
The study, sponsored by Eli Lilly and Company, involved 669 women with HR+, HER2- advanced breast cancer.
The additional indication is the second FDA approval for AstraZeneca’s Faslodex in combination with a CDK4/6 inhibitor.
Last year, the therapy was licensed in the US for use with the CDK4/6 inhibitor, palbociclib, to treat women with HR+, HER2- MBC, whose cancer has progressed after endocrine therapy.
