FRIDAY July 20, 2012 — Afinitor (everolimus) has been approved in combination with the drug exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer, the U.S. Food and Drug Administration said Friday.
The newly approved combination is sanctioned for women whose cancer has progressed or returned despite previous use of the drugs letrozole (Femara) or anastrozole (Arimidex), the agency said in a news release.
Breast cancer, the second-leading cause of cancer death among women, is expected to be newly diagnosed in an estimated 226,870 women this year and cause about 39,510 deaths, the FDA said.
Afinitor — already sanctioned for uses including treating certain forms of advanced renal cell carcinoma — was clinically evaluated for the new use among 724 people with advanced breast cancer. People who took the combination drug had a 4.6-month improvement in the average time to disease progression or death, compared to those who took a placebo.
The most common side effects among those taking Afinitor were mouth ulcers, infection, rash, fatigue, diarrhea and loss of appetite.
Afinitor is marketed by Novartis, based in East Hanover, N.J.