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FDA NEWS RELEASE

For Immediate Release: July 20, 2012
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov  
Consumer Inquiries: 888-INFO-FDA

FDA approves Afinitor for advanced breast cancer


The U.S. Food and Drug Administration today approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.
 
The drug combination is intended for use in women with recurrence or progression of their cancer after treatment with Femara (letrozole) or Arimidex (anastrozole).
 
Breast cancer is the second leading cause of cancer-related death among women. This year an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will die from 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.”
 
The safety and effectiveness of Afinitor was evaluated in a clinical study of 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 were selected to receive either Afinitor in combination with Aromasin or Aromasin with a placebo (sugar pill). Patients 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 had a 4.6 month improvement in the median time to disease progression or death compared to patients receiving the placebo plus Aromasin.
 
The most common side effects observed in patients receiving Afinitor for breast cancer were mouth ulcers, infections, rash, fatigue, diarrhea and decreased appetite. Patients aged 65 years and older should be monitored closely as these patients experience a higher rate of serious side effects than younger patients receiving the treatment.
 
The FDA has previously approved Afinitor 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.
 
Afinitor is marketed by East Hanover, N.J.-based Novartis Pharmaceuticals Corporation.
 

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