The US Food and Drug Administration (FDA) has approved a higher, more efficacious dose of fulvestrant (Faslodex, AstraZeneca) injection for treatment of metastatic breast cancer. The newly approved dose of 500 mg replaces the previously approved monthly dose of 250 mg for the treatment of hormone receptor–positive (HR+) metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
The approval was based on results from the Comparison of Faslodex in recurrent or metastatic breast cancer (CONFIRM) study. This trial showed that the 500-mg dose reduced the time to disease progression by 20% compared with the 250-mg dose, with comparable safety and tolerability.