CHMP recommends approval of change in indication for Faslodex (fulvestrant) in breast cancer.- AstraZeneca.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Faslodex (fulvestrant), from AstraZeneca, in breast cancer. The CHMP adopted an extension to the existing new indication as follows: “Faslodex is indicated: • as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: ? not previously treated with endocrine therapy, or ? with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. • in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.”

Comment: The National Institute of Health and Care Excellence (NICE) recently released draft guidance recommending against use of Faslodex as an option for delaying growth of estrogen-receptor-positive breast cancer that has spread to other parts of the body in patients who have not yet been treated with hormonal therapy. NICE considers that Faslodex does not show that it extends survival more than less expensive therapies. Faslodex has showed it can delay cancer growth by about three months more than aromatase inhibitors but according to NICE, it is too early to determine from the available evidence whether this effect translates into an increase in overall survival benefit.