The US Food and Drug Administration (FDA) has approved fulvestrant 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 FDA approval is based on pivotal data from the Phase III FALCON trial, which were published in the November 2016 issue of The Lancet.

This follows the EU approval of front-line fulvestrant in July.

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

The FALCON trial was designed to demonstrate superiority and 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 determined by RECIST - median PFS of 16.6 months in patients who received fulvestrant, compared to 13.8 months in patients receiving the aromatase inhibitor anastrozole1mg (HR: 0.797; 95% CI: 0.637-0.999; p=0.049).

Fulvestrant is 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.

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

Jamie Freedman, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca said “We’re pleased that the landmark FALCON trial results demonstrated the efficacy of fulvestrant as initial monotherapy treatment for women who are living with HR , HER2- advanced breast cancer. This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive fulvestrant earlier in the treatment journey.”

Source: BusinessWire