Monday the U.S. Food and Drug Administration approved a new drug for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with an advanced type of breast cancer.
The drug Afinitor (everolimus) is intended in combination with Aromasin (exemestane) for use in postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer after recurrence or progression of their cancer after treatment with Femara (letrozole) or Arimidex (anastrozole).
Breast cancer is the second largest cause of cancer-related death among women. In 2012 an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will lose their lives to the disease.
"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," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval."
A clinical study evaluated safety and effectiveness of Afinitor in 724 patients with advanced breast cancer. All patients had experienced menopause, had estrogen receptor-positive, HER2-negative breast cancer that had spread, and had previously received treatment with Femara or Arimidex. Patients received either Afinitor in combination with Aromasin or Aromasin with a placebo. Each received treatment until their cancers progressed or side effects became unacceptable.
The study was designed to measure the length of time a patient lived without the cancer progressing, or progression-free survival (PFS). Patients who were assigned to receive Afinitor plus Aromasin combination experienced a 4.6 month improvement in the median time to disease progression or death compared to patients receiving the placebo plus Aromasin.
Mouth ulcers, infections, rash, fatigue, diarrhea and decreased appetite were the most common side effects observed in patients receiving Afinitor for breast cancer. Patients aged 65 years and older should be monitored closely as this group of patients experience a higher rate of serious side effects than younger patients treated.
Afinitor was previously approved by the FDA to treat patients with advanced renal cell carcinoma that has progressed after treatment with other cancer therapies, in adult patients with progressive advanced neuroendocrine tumors of pancreatic origin, for patients with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery, and for adults and children with subependymal giant cell astrocytoma associated with TSC who require treatment but are not candidates for curative surgery.
East Hanover, N.J.-based Novartis Pharmaceuticals Corporation markets Afinitor.