AstraZeneca announced that the European Commission has approved Faslodex (fulvestrant) for the treatment of a type of advanced breast cancer.
The EU approval is based on data from the Phase III FALCON trial.
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 of this type of 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 Faslodexat 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, 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, said: “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. 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.”
The safety and tolerability profiles for Faslodex and anastrozole reported in the FALCON trial were in line with current experience.
Faslodex is the only hormonal medicine for advanced breast cancer that slows tumor growth by binding to and degrading the estrogen receptor – a key driver of breast cancer progression in some women
Faslodex was first approved in 2002 and is currently being tested in combination with over 19 different medicines for the treatment of women with advanced HR+ breast cancer.
AstraZeneca has a North America commercial headquarters in north Wilmington and a packaging-distribution operation south of Newark.
