Afinitor Gets the Nod for Metastatic Breast Cancer

September 2012, Vol 3, No 6 - FDA Approvals, News & Updates


The FDA approved the mTOR in­hib­itor everolimus (Afinitor; Novartis) for use in combination with exemestane (Aromasin) for the treatment of postmenopausal women with ad­vanced hormone-receptor–positive, HER2-negative breast cancer, who had disease recurrence or progression after receiving letrozole (Femara) or anastrozole (Arimidex). The approval was based on a study of 724 postmeno­pausal women with estrogen-receptor–positive, HER2-negative advanced breast cancer that had spread despite previous therapy with letrozole or anastrozole. Patients randomized to the everolimus plus exemestane combination had a 4.6-month im­provement in the median time to disease progression or death compared with those receiving placebo plus exemestane.

Everolimus is already FDA approved for the treatment of patients with advanced renal-cell carcinoma that has progressed after treatment with other cancer therapies. (July 20, 2012)