AstraZeneca said in a release its hormone-therapy breast cancer drug Faslodex (fulvestrant) has been authorized for a second look by European Commission (EC) regulators.
Already approved for use in the U.S., Faslodex showed in a clinical trial it was effective against forms of breast cancer that are hormone-receptor positive, the release said. Compared to standard-of-care drug anastrozole, Faslodex gave patients nearly three months of extra time before the disease worsened.
Based on the study, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended its approval to EC regulators, the release said. If given the go-ahead by the EC, Faslodex could wind up in use in more than 30 European and Scandinavian countries.
Sean Bohen, AstraZeneca executive vice president of global medicines development, lauded the EMA’s decision to recognize the drug’s efficacy.
“Faslodex is also being tested in combination with over 19 different medicines, which is testament to its well-established safety and efficacy profile with over 15 years of patient evidence since its first launch in 2002,” Bohen said in the release.
Faslodex, which inhibits estrogen’s ability to spur the growth of certain tumors, is often prescribed for women in menopause whose breast cancer is unresponsive to other forms of treatment.