Afinitor Gets the Nod for Metastatic Breast Cancer
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)