The US Food and Drug Administration gave the green light for use of a drug combination to advanced breast cancer.
Peter A. Kaufman, MD of the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, said: “This new indication forFaslodexoffers another treatment option for women living with HR+, HER2- advanced or metastatic breast cancer with disease progression after endocrine therapy. The study supporting this indication demonstrated thatFaslodexused in combination with abemaciclib significantly improves progression-free survival compared toFaslodexand placebo.”
The FDA approval is based on data from a Phase III trial.
This expanded indication forFaslodexis the second FDA approval forFaslodexin combination with a CDK4/6 inhibitor.
Faslodexhas been licensed in the US since 2016 for use with the CDK4/6 inhibitor, palbociclib, for the treatment of women with HR+, HER2-negative MBC, whose cancer has progressed after endocrine therapy.
AstraZeneca, at last report, had about 1,500 employees.