(RxWiki News) The U.S. Food and Drug Administration has approved a drug to be used for postmenopausal women with advanced hormone-receptor positive and HER2-negative breast cancer.
Afinitor (everolimus) has been approved for use with Aromasin (exemestane) for women whose breast cancer has either returned or gotten worse following treatment with two hormone blocking drugs.
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“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, MD, 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 tested in a clinical study involving 724 patients with advanced breast cancer. All of the women were postmenopausal and had estrogen receptor-positive (ER+), HER2-negative breast cancer that had spread (metastasized).
The women had previously been treated with either Arimidex or Femara. For the study, participants were assigned to receive a combination of Afinitor and Aromasin or Aromasin with a sugar pill (placebo). Treatment lasted until the cancers continued or side effects became intolerable.
Researchers found that women who received the combination therapy had 4.6 months improvement in median time before cancer progression, compared to women receiving the placebo and Aromasin.
The most common side effects seen in women taking the Afinitor 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 Novartis Pharmaceuticals Corporation.