AstraZeneca's Faslodex Recommended By CHMP For 1st Line Use
Zacks Investment Research | Jun 26, 2017 10:44PM ET
AstraZeneca PLC (NYSE:AZN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorisation of Faslodex (fulvestrant) for 1st-line treatment for postmenopausal women with HR+ advanced breast cancer.
Presently, Faslodex is approved for advanced breast cancer in later lines of treatment. Faslodex is used to treat postmenopausal women with hormone receptor - positive metastatic breast cancer whose disease has spread after treatment with antiestrogen medicine. It is also is also approved, in combination with Pfizer Inc.’s (NYSE:PFE) Ibrance (palbociclib), for the treatment of women with HR+, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine.
AstraZeneca is looking to get the drug approved for the treatment of HR+ locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-estrogen therapy.
AstraZeneca’s shares have outperformed the Zacks classified .
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