FDA Greenlights Fulvestrant Monotherapy for Expanded Use in Advanced Breast Cancer

The FDA granted approval today to fulvestrant (Faslodex) as a monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

The approval is based on pivotal data from the phase 3 FALCON Trial, according to a press release. It is indicated for women who have gone through menopause and have not received previous endocrine therapy.

“We’re pleased that the landmark FALCON trial results demonstrated the efficacy of Faslodex as initial monotherapy treatment for women who are living with HR+, HER2- advanced breast cancer,” Jamie Freedman, executive vice president, head of the Oncology Business Unit at AstraZeneca, said in a press release. “This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to received Faslodex earlier in the treatment journey.”

The randomized, double-blind, multicenter FALCON trial compared the efficacy and tolerability of a 500-mg dose of fulvestrant plus placebo with a 1-mg dose of anastrozole (Arimidex) plus placebo in postmenopausal women with HR+, locally-advanced or metastatic breast cancer, who have not had prior endocrine therapy.

“This study provides evidence that using fulvestrant as the first option for previously untreated hormone receptor-positive advanced breast cancer will prolong the time before the disease advances and alternative therapies are required,” Matthew Ellis, MD, PhD, director of the Lester and Sue Smith Breast center, said in the release.

The study, which was designed to demonstrate superiority, included 462 postmenopausal women with HR+ metastatic or locally-advanced breast cancer.

The results showed a statistically significant increase in investigator-assessed median progression-free survival (PFS), representing a 20% reduction in the risk of disease progression or death.

The median PFS was 16.6 months among patients in the fulvestrant arm compared with 13.8 months in the anastrozole arm.

The most common adverse events of any grade reported in the fulvestrant arm were arthralgia, hot flash, fatigue, and nausea.

Fulvestrant is a hormonal therapy designed to target the estrogen receptor and help slow cancer growth by blocking the ER and targeting it for