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FDA approves Faslodex in combination with Verzenio for advanced breast cancer
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The FDA expanded the indication of fulvestrant to include its use with abemaciclib for treatment of certain women with advanced or metastatic breast cancer.
The approval applies to use of fulvestrant (Faslodex, AstraZeneca) — an ER antagonist — and the CDK4/6 inhibitor abemaciclib (Verzenio, Eli Lilly) for women with hormone receptor-positive, HER-2-negative disease that progressed after endocrine therapy.
“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 and head of the oncology business unit at AstraZeneca, said in a press release. “[This] 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, nonchemotherapy option to combat this disease.”
The FDA based the approval on results from the randomized, double-blind, placebo-controlled phase 3 MONARCH 2 trial.
The trial included 669 women (median age, 60 years, range, 32-91; 56% white) with hormone receptor-positive, HER-2-negative advanced breast cancer whose disease progressed on or after neoadjuvant or adjuvant endocrine therapy, 1 year or less from the end of adjuvant endocrine therapy, or during first-line endocrine therapy for metastatic disease.
All patients had ECOG performance status of 0 or 1.
Researchers randomly assigned women 2:1 to 500 mg fulvestrant via intramuscular injection with either abemaciclib or placebo orally twice daily.
Treatment continued until disease progression or unmanageable toxicity. PFS served as the primary endpoint.
As HemOnc Today previously reported, results showed significantly longer investigator-assessed median PFS in the fulvestrant-abemaciclib group (16.4 months vs. 9.3 months; HR = 0.55; 95% CI, 0.44-0.68).