AstraZeneca’s faslodex receives EU approval for advanced breast cancer treatment


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

Faslodex is the only hormonal treatment available for advanced breast cancer that slows down tumour growth by binding to and degrading the oestrogen receptor, which is a major factor causing breast cancer progression in some women.

The approval for faslodex in the European Union (EU) is based on pivotal data from the randomised, double-blind, multicentre, Phase III FALCON trial, which showed the effectiveness of faslodex at 500mg over anastrozole at 1mg.

The study demonstrated that faslodex at 500mg can be used as a first-line treatment for postmenopausal women with locally advanced or HR+ metastatic breast cancer who had not been treated with prior hormone-based therapy.

"This new EU approval shows the scientific strength of faslodex with more than 15 years of clinical experience."

AstraZeneca oncology business unit executive vice-president and head Jamie Freedman said: “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.”

In 2002, the AstraZeneca treatment was first approved and is currently being tested in combination with more than 19 different medicines for the treatment of women with advanced HR+ breast cancer.

In the US, faslodex is also approved in combination with palbociclib for the treatment of women with HR+, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine.


Image: Concept design of AstraZeneca Global R&D centre and corporate headquarters, Cambridge, UK. Photo: © Herzog & de Meuron / AstraZeneca.