AstraZeneca’s Faslodex recommended for EU breast cancer approval

AstraZeneca has announced that its cancer therapy Faslodex has been recommended for European regulatory approval as a treatment for certain forms of breast cancer.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Faslodex, based on positive phase III clinical trial data.

If approved, Faslodex would be used in the treatment of hormone receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women who have not previously been treated with endocrine therapy, with disease relapse on or after adjuvant anti-oestrogen therapy, or whose disease has progressed on anti-oestrogen therapy.

Data from the phase III FALCON trial indicated that Faslodex demonstrated superiority over an established alternative in the treatment of locally advanced or metastatic breast cancer in postmenopausal women who had not received prior treatment.

Sean Bohen, executive vice-president for global medicines development and chief medical officer at AstraZeneca, said: "Faslodex has long been an effective medicine for women with advanced breast cancer in later lines of treatment and we are pleased that the CHMP has recognised its potential as a first-line option."

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