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Faslodex gets US FDA OK for expanded use in breast
Faslodex gets US FDA OK for expanded use in breast.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 1351P AstraZeneca PLC 29 August 2017 \n\nThis announcement contains inside information\n \n29 August 2017 07:00 BST\n \nFASLODEX RECEIVES US FDA APPROVAL aS MONOTHERAPY FOR Expanded use IN breast cancer \n \n20% reduction in disease progression vs anastrozole, a current standard treatment option\n \nExpanded approval provides earlier benefit for advanced breast cancer patients not previously treated with endocrine therapy\n \nAstraZeneca today announced that the US Food and Drug Administration (FDA) has 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.\n \nThe FDA approval is based on data from the Phase III FALCON trial, which were published in the November 2016 issue of The Lancet. \n \nJamie Freedman, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca 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.\"\n\nMatthew Ellis, MD, PhD, Director of the Lester and Sue Smith Breast Center, part of the NCI-designated Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, said: \"This study provides evidence that using fulvestrant as the first option for previously untreated hormone receptor-positive advanced breast cancer will prolong the time before the disease advances and alternative therapies are required.\"\n \nThe FALCON trial was designed to demonstrate superiority and included 462 postmenopausal women with HR+ metastatic or locally-advanced breast cancer. The results showed a statistically-significant increase in investigator-assessed median progression-free survival (PFS), representing a 20% reduction in the risk of disease progression or death - median PFS of 16.6 months in patients who received Faslodex, compared to 13.8 months in patients receiving the aromatase inhibitor ...