AstraZeneca announced that the Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) as monotherapy for use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who are postmenopausal and have not received previous endocrine therapy.

The approval was supported by data from the Phase 3 FALCON trial (n=462) that enrolled postmenopausal women with HR+ metastatic or locally advanced breast cancer. The study data showed a statistically significant increase in investigator-assessed median progression-free survival (PFS) with a 20% reduction in the risk of disease progression or death in Faslodex-treated patients vs. Arimidex (anastrozole)-treated patients (16.6 vs. 13.8 months; hazard ratio [HR] 0.797, 95% CI: 0.637–0.999; P=0.049)  

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Faslodex, an estrogen receptor antagonist, is already approved to treat HR+ metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy, and for use in combination with palbociclib to treat HR+, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy.

Faslodex is available as 50mg/mL strength pre-filled syringes for intramuscular injection.

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