EU OKs first-line use of AZ’ Faslodex

Specifically, the European Commission has cleared the drug’s use to treat oestrogen-receptor positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

The approval is based on findings of the Phase III FALCON trial, which showed that Faslodex (fulvestrant) was superior to aromatase inhibitor anastrozole as a first-line treatment for the target patient population.

According to the data, median progression-free survival (PFS) was significantly longer with Faslodex than with anastrozole, at 16.6 months versus 13.8 months.

"A 20 percent reduction in disease progression or death observed with fulvestrant compared to the current standard therapy is an advance in the management of postmenopausal women diagnosed with previously untreated hormone receptor-positive advanced breast cancer," noted Matthew Ellis, study investigator, and director of the Lester and Sue Smith Breast Center in the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine in Houston.

"The study provides evidence that the earlier use of fulvestrant in these patients will prolong the time before the disease progresses, which requires a change to a second line drug."

Faslodex, which was first approved for breast cancer back in 2002 as a second-line option, is the only hormonal medicine for advanced breast cancer that slows tumour growth by binding to and degrading the oestrogen receptor - a key driver of disease progression in some women, AZ said.