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FDA Approves New Indication for FASLODEX (fulvestrant)

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Additional Relevant Details AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication expanding the use of FASLODEX (fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy.1FASLODEX has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.







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Catalyst Date
Occurred on:
Mar 02, 2016
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Related Keywords Fda, Faslodex, Fulvestrant, Her2- Metastatic Breast Cancer, Postmenopausal Women With Hr+ Mbc, Tumor, Palbociclib, Phase Iii Paloma-3 Trial, Menopausal Status