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AstraZeneca’s Faslodex receives EU approval


The European Commission (EC) has approved Faslodex (fulvestrant) for the treatment of oestrogen-receptor positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

The EU approval is based on pivotal data from the Phase III FALCON trial, which demonstrated the superiority of Faslodex 500mg over anastrozole 1mg as a first-line treatment for postmenopausal women with locally-advanced or HR+ metastatic breast cancer who had not received prior hormone-based therapy.

In the FALCON trial, median progression-free survival (PFS) was significantly longer with Faslodex than with the aromatase inhibitor, anastrozole – 16.6 months versus 13.8 months (HR: 0.797; 95% CI: 0.637-0.999; p=0.0486). Aromatase inhibitors such as anastrozole are the current standard of care for the first-line treatment for postmenopausal women with HR+ advanced breast cancer.

“This new EU approval shows the scientific strength of Faslodex with more than 15 years of clinical experience. Postmenopausal women with hormone receptor-positive advanced breast cancer can now benefit from Faslodex at an earlier stage in their disease. We continue to explore the full potential of this important medicine as monotherapy and in combination with other medicines,” said Jamie Freedman, Executive Vice-President and Head of AstraZeneca’s Oncology Business Unit.

The safety and tolerability profiles for Faslodex and anastrozole reported in the FALCON trial were in line with current experience. The most-commonly reported adverse events (AEs) in the Faslodex and anastrozole arms were arthralgia (16.7% vs. 10.3%), hot flush (11.4% vs. 10.3%) and nausea (10.5% vs. 10.3%).

Faslodex is the only hormonal medicine for advanced breast cancer that slows tumour growth by binding to and degrading the oestrogen receptor – a key driver of breast cancer progression in some women. It is widely approved for the treatment of HR+ advanced breast cancer in postmenopausal women with disease progression following anti-oestrogen medicine. Faslodex was first approved in 2002 and is currently being tested in combination with over 19 different medicines for the treatment of women with advanced HR+ breast cancer.