The FDA approved everolimus for use with exemestane to treat certain postmenopausal women with advanced hormone receptor-positive, HER-2–negative breast cancer.
The drug combination is intended for use in women with recurrence or progression of their cancer after treatment with letrozole (Femara, Novartis Pharmaceuticals) or anastrozole (Arimidex, AstraZeneca).
The FDA based its approval on a clinical study that evaluated the safety and effectiveness of everolimus (Afinitor, Novartis) in 724 patients with advanced breast cancer. All patients had experienced menopause, and they had estrogen receptor-positive, HER-2–negative breast cancer that had spread. All patients had received prior treatment with letrozole or anastrozole.
Patients were selected to receive either everolimus combined with exemestane (Aromasin, Pharmacia and Upjohn) or exemestane with a placebo. Patients received treatment until their cancers progressed or adverse effects became unacceptable.
The everolimus plus exemestane combination extended median PFS by 4.6 months compared with the placebo plus exemestane combination, study results showed.
“This is the first approval from the class of drugs known as mTOR inhibitors for the treatment of postmenopausal women with advanced hormone-receptor positive breast cancer,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval.”
The most common adverse effects observed in patients who received everolimus for breast cancer were mouth ulcers, infections, rash, fatigue, diarrhea and decreased appetite. Patients aged 65 years and older experienced a higher rate of serious adverse effects than younger patients, so the FDA recommended that patients in that demographic be monitored closely.
The FDA previously approved everolimus to treat several other patient populations, including: patients with advanced renal cell carcinoma that has progressed after treatment with other cancer therapies; adult patients with progressive advanced neuroendocrine tumors of pancreatic origin; patients with renal angiomyolipoma and tuberous sclerosis complex who do not require immediate surgery; and adults and children with subependymal giant cell astrocytoma associated with tuberous sclerosis complex who require treatment but are not candidates for curative surgery.