Date: 2016-11-28
Type of
information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in The Lancet
Company: AstraZeneca (UK)
Product: Faslodex® (fulvestrant)
Action
mechanism:
- oestrogen receptor antagonist. Faslodex® (fulvestrant) is an estrogen receptor antagonist indicated for the treatment of postmenopausal women with ER+, locally-advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen. In the US, Faslodex® 500mg is also approved, in combination with palbociclib, for the treatment of US women with HR+, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC), whose cancer has progressed after endocrine therapy. Faslodex 500mg represents a hormonal therapy approach that helps to slow tumour growth by blocking and degrading the oestrogen receptor.
Disease: hormone receptor positive breast cancer
Therapeutic
area: Cancer - Oncology
Country: Argentina, Brazil, Canada, China, Czech Republic, India, Italy, Japan, Mexico, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Turkey, Ukraine, UK, USA
Trial
details:
- The FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naïve advanced breast cancer) trial is a Phase III, randomised, double-blind, multicentre trial. The trial compared the anti-tumour effects and tolerability profile of a 500mg dose of Faslodex® plus placebo with a 1mg dose of Arimidex® plus placebo, in postmenopausal women with hormone-receptor-positive, locally-advanced or metastatic breast cancer who have not been treated previously with any hormonal therapy. (NCT01602380)
Latest
news:
- • On November 28, 2016, results of the Phase III FALCON trial have been published in The Lancet. In this trial, 462 patients were randomised (230 to receive fulvestrant and 232 to receive anastrozole). Progression-free survival was significantly longer in the fulvestrant group than in the anastrozole group (hazard ratio [HR] 0·797, 95% CI 0·637–0·999, p=0·0486). Median progression-free survival was 16·6 months (95% CI 13·83–20·99) in the fulvestrant group versus 13·8 months (11·99–16·59) in the anastrozole group.
- • On May 27, 2016, AstraZeneca announced positive results from the Phase III FALCON trial comparing Faslodex® 500mg (fulvestrant) to Arimidex® 1mg (anastrozole) for the treatment of locally-advanced or metastatic breast cancer, in post-menopausal women who have not had prior hormonal treatment for hormone-receptor-positive (HR+) breast cancer. Faslodex® 500mg demonstrated superiority compared with Arimidex® 1mg in FALCON, and met its primary endpoint of extended progression-free survival. The trial showed an adverse event profile generally consistent with current knowledge of the safety profile of the medicines. A full evaluation of the data is ongoing and the results are expected to be presented at a medical meeting in 2016.
Is
general: Yes
