According to AstraZeneca, the US Food and Drug Administration (FDA) granted the pharmaceutical Company an approval on replacing the monthly 250 mg dose of Faslodex (fulvestrant) injection with a 500 mg dose.
Faslodex injections are used as a treatment for postmenopausal women with disease progression after having an antiestrogen therapy, against hormone receptor-positive metastatic breast cancer.
The approval was granted subsequent to the study carried out by CONFIRM (COmparisoN of Faslodex In Recurrent or Metastatic breast cancer), which provided data that the 500 mg dose of Faslodex has the ability to reduce the risk of disease progression by 20%, in comparison to the 250 mg Faslodex dose.
Gershon Locker, the Medical Director for AstraZeneca stated that the approval would increase the women’s ability to stop the progression of the metastatic breast cancer.
He added, “FASLODEX at 250mg has been an important treatment option for many women, and we now have data to show that the new 500mg dosing regimen can improve progression free survival compared with the 250mg dose”.
However, Objective Response Rates released some figures revealing that patients did not show any significant differences, when they used either of Faslodex’s doses, the 500 mg and the 250 mg.