The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a new indication for fulvestrant that will expand its use to include combination therapy with palbociclib.

The combination use is for 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.

Fulvestrant slows tumour growth by binding to and degrading the oestrogen receptor - a key driver of breast cancer progression in some women.

It is widely approved for the treatment of HR advanced breast cancer in postmenopausal women with disease progression following anti-oestrogen medicine.

The CHMP opinion is based on data from the Phase III PALOMA-3 trial.

The combination of fulvestrant 500 mg and palbociclib 125 mg resulted in a 4.9 month progression-free survival (PFS) improvement over fulvestrant and placebo in women with HR , HER2- advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in PFS was seen regardless of menopausal status.

The most-commonly reported adverse events (AEs) in fulvestrant plus palbociclib compared to fulvestrant plus placebo were neutropenia (81% vs 3%), leukopenia (50% vs 4%) and infections (42% vs 30%).2

Fulvestrant is approved in over 80 countries as a monotherapy to treat ER advanced breast cancer patients.

It is currently being evaluated in combination with over 19 different medicines for the treatment of women with HR advanced breast cancer.

Most recently, fulvestrant was approved in Japan by the Pharmaceuticals and Medical Devices Agency for use in combination with a CDK4/6 inhibitor.

Klaus Edvardsen, Head of Oncology Global Medicines Development at AstraZeneca 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.”

Source: BusinessWire