The FDA has approved a higher dose of Faslodex (fulvestrant) Injection for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women whose disease has progressed following antiestrogen therapy. The newly approved Faslodex dose is 500mg, replacing the previously approved monthly dose of 250mg.
The FDA has approved the dosage on the basis of the phase III CONFIRM study (COmparisoN of Faslodex In Recurrent or Metastatic breast cancer), which indicated that the higher, 500mg dose substantially reduced the risk of disease progression in this patient population compared to the 250mg dose while maintaining the drug's safety and tolerability profile.
CANCER TYPE(S)
Hormone receptor-positive metastatic breast cancer
TREATMENT TYPE(S)
Selective Estrogen Receptor Down-Regulator (SERD)
Source
MarketWatch
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