AstraZeneca has received approval from the US Food and Drug Administration (FDA) for a new indication of its Faslodex (fulvestrant) to treat women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC).
The approval expands use of Faslodex to include use in combination with Ibrance (palbociclib).
Fulvestrant is indicated in the European Union to treat postmenopausal women with oestrogen receptor positive, locally advanced or MBC for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.
It represents a hormonal therapy approach that targets the ER, which is a key driver of disease progression.
Fulvestrant helps to slow tumour growth by blocking and degrading the ER.
The FDA approval is based on the the Phase III PALOMA-3 trial, which met the study’s primary endpoint of progression-free survival.
The double-blind, parallel group, multicentre study evaluated the efficacy of fulvestrant plus palbociclib versus fulvestrant plus placebo in women with HR+ / HER2- advanced or MBC, without taking their menopausal status into consideration, whose disease progressed after endocrine therapy.
AstraZeneca oncology, global medicines development head Antoine Yver said: "This new indication in the US is encouraging news for metastatic breast cancer patients.
"As a company we are committed to optimising the current standard of care in breast cancer. To achieve this, we are exploring combinations across different scientific platforms through ongoing research and evaluation."
MBC is the most advanced stage of breast cancer, and occurs when cancer cells have spread beyond the initial tumour site to other parts of the body outside of the breast. Currently, there is no cure for this disease.
Image: AstraZeneca’s R&D Site in Mölndal, Sweden. Photo: courtesy of Erik031.