FDA approves AstraZeneca’s faslodex for expanded use in breast cancer
AstraZeneca’s faslodex (fulvestrant) at 500mg has received approval from the US Food and Drug Administration (FDA) as monotherapy for expanded use in women with advanced breast cancer.
The hormonal therapy can be used 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 previously received endocrine treatment.
Faslodex targets the oestrogen receptor (ER) affecting the growth of HR+ metastatic breast cancer (MBC) and helps slow down cancer growth by blocking the ER and targeting it for degradation.
The FDA approval for the treatment is based on data derived from the randomised, double-blind, multicentre Phase III Falcon trial conducted to compare the anti-tumour effects and tolerability profile of a 500mg dose of faslodex plus placebo with a 1mg dose of anastrozole plus placebo.
AstraZeneca executive vice-president and oncology business unit head Jamie Freedman said: “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.
“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.”
The Phase III Falcon trial involved 462 postmenopausal women with HR+ metastatic or locally advanced breast cancer.
The results demonstrated a statistically significant increase in investigator-assessed median progression-free survival (PFS), showing a 20% reduction in the risk of disease progression or death.
The company has also entered an agreement with Takeda Pharmaceutical to jointly develop and market MEDI1341 for the treatment of patients with Parkinson’s disease (PD).
MEDI1341 is an alpha-synuclein antibody currently under development that is differentiated by its high affinity, high selectivity and reduced effector function.
Under the deal, Takeda will pay up to $400m to AstraZeneca, including initial revenue for this year along with development and sales milestones.