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AZ breast cancer drug gets FDA approval

29 August 2017 07:48

AstraZeneca's breast cancer drug Faslodex has received approval from the the US Food and Drug Administration.

AstraZeneca said the FDA had approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use 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 received previous endocrine therapy.

It said the FDA approval was based on data from the phase III FALCON trial, which were published in the November 2016 issue of The Lancet.

Executive vice-president, head of the oncology business unit, 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."

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