AstraZeneca's Faslodex gets expanded FDA approval

AstraZeneca announced on Tuesday that the US Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy.

The FTSE 100 drugmaker said the FDA approval was based on data from the Phase III FALCON trial, which were published in the November 2016 issue of The Lancet.

“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,” said AstraZeneca executive vice president and head of the oncology business unit Jamie Freedman.

“This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive Faslodex earlier in the treatment journey.”

AstraZeneca said the FALCON trial was designed to demonstrate superiority, and included 462 postmenopausal women with HR+ metastatic or locally-advanced breast cancer.

The results reportedly 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 - median PFS of 16.6 months in patients who received Faslodex, compared to 13.8 months in patients receiving the aromatase inhibitor anastrozole 1mg.

Astrazeneca described Faslodex as a hormonal therapy that targets the oestrogen receptor (ER), which can influence the growth of HR+ metastatic breast cancer (MBC), and helps to slow cancer growth by blocking the ER and targeting it for degradation.

It said the most common adverse reactions (≥10%) of any grade reported in patients in the Faslodex arm were arthralgia, hot flash, fatigue, and nausea.

“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,” commented Matthew Ellis, director of Lester and Sue Smith Breast Center, part of the NCI-designated Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine.