The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for AstraZeneca’s Faslodex (fulvestrant) to treat hormone receptor-positive (HR+) advanced breast cancer in combination with palbociclib.
The EMA recommendation for the new indication includes the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
Advanced / metastatic breast cancer refers to Stage III and IV breast cancer.
Fulvestrant can be used to treat oestrogen 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 anti-oestrogen therapy, or disease progression on anti-oestrogen therapy.
The therapy is used to slow down tumour growth by binding to and degrading the oestrogen receptor, which is a major cause of breast cancer progression in some women.
AstraZeneca Oncology Global Medicines Development head Klaus Edvardsen said: “This positive CHMP opinion builds on the growing body of evidence around the potential of fulvestrant in combination with targeted therapies, such as palbociclib.
“Fulvestrant-based treatment regimens may provide new options for patients with advanced breast cancer for whom there is still an unmet medical need.
“This is why many current clinical trials exploring the effects of combination therapies in this patient population are using fulvestrant.”
The current CHMP opinion is based on data obtained from the international, randomised, double-blind, parallel group, multicentre Phase III PALOMA-3 trial of fulvestrant plus palbociclib versus fulvestrant plus placebo.
The study involved 521 women with HR+ / HER2- advanced or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after endocrine therapy.
The treatment is currently approved in more than 80 countries as a monotherapy to treat ER+ advanced breast cancer.