New EU approval for AstraZeneca’s certain breast cancer treatment

AstraZeneca today announced that the European Commission (EC) has approved Faslodex (fulvestrant) for certain metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

In the FALCON trial, median progression-free survival (PFS) was significantly longer with Faslodex than with the aromatase inhibitor, anastrozole – 16.6 months versus 13.8 months. Aromatase inhibitors such as anastrozole are the current standard of care for the first-line treatment for postmenopausal women with HR+ advanced breast cancer.

Jamie Freedman, Executive Vice-President and Head of AstraZeneca’s Oncology Business Unit, said: “This new EU approval shows the scientific strength of Faslodex with more than 15 years of clinical experience. Postmenopausal women with hormone receptor-positive advanced breast cancer can now benefit from Faslodex at an earlier stage in their disease. We continue to explore the full potential of this important medicine as monotherapy and in combination with other medicines.”

Matthew Ellis, director of the Lester and Sue Smith Breast Center in the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine in Houston, said: “A 20% 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. 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.”