NICE has today (Friday 1 September) published draft guidance which does not recommend fulvestrant (known commercially as Faslodex and manufactured by AstraZeneca) as a treatment for post-menopausal women with hormone positive, locally advanced or metastatic breast cancer who have not already had treatment with hormone therapy (aromatase inhibitors or tamoxifen).

Although NICE accepts that fulvestrant stalls the cancer’s growth by around three months (compared to the standard treatment of aromatase inhibitors), they concluded that it is too early to say from the available evidence if this leads to an increase in overall survival.

It is estimated that around 1,200 postmenopausal women diagnosed with breast cancer would be eligible for first-line treatment with fulvestrant each year in England.

Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“This is very disappointing news. New options for women with this type of breast cancer are long overdue, and, while fulvestrant’s ultimate survival benefit remains uncertain, it offers a valuable advance in treatment.

“Fulvestrant can give some women nearly three extra months before their breast cancer progresses compared to the standard treatment of aromatase inhibitors, often with only mild side effects. Crucially, it can also delay the need for some women to begin chemotherapy, time which can be so important to many.

“But unfortunately fulvestrant finds itself in a position where it cannot win. The uncertainty over its survival benefit means it cannot be deemed cost-effective, but, as a hormone therapy, it also cannot be made available through the Cancer Drugs Fund while further data is collected, as this type of drug is not funded centrally by NHS England.

“Options such as palbociclib or ribociclib may yet hold this type of breast cancer at bay even more effectively, but they are currently being appraised by NICE and we cannot assume they will be made routinely available to NHS patients. We hope fulvestrant will be reappraised as soon as better data on its survival benefit is available, to ensure that patients can benefit from this advance."