AstraZeneca announced promising results from the Phase III FALCON trial of fulvestrant (500mg) compared to anastrozole (1mg) in the 1st line treatment of women with a type of advanced breast cancer.
The FALCON trial enrolled 462 patients.
Professor Matthew Ellis, principal investigator of the FALCON trial, said: “These data document a benefit for fulvestrant in delaying disease progression as a first line therapy, an important goal for women with metastatic breast cancer. The results are supported by a previous trial, which also showed an advantage for fulvestrant over anastrozole. The results are clinically meaningful and suggest that fulvestrant could be used as 1st line therapy for women with advanced breast cancer.”
The safety and tolerability profile was in line with current experience with fulvestrant and anastrozole.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Fulvestrant has over 10 years of clinical evidence to support its use, and we are continuing to evaluate its full potential in advanced breast cancer, where we believe patient need is currently the greatest. AstraZeneca has a long, rich heritage in breast cancer research, and we remain committed to investigating innovative potential medicines for the treatment of women with all types of advanced disease.”
AstraZeneca is now in discussions with US regulatory authorities about a planned regulatory submission for a potential label extension.
