FDA Approves Afinitor for Advanced Breast Cancer
Afinitor, which already has been approved for treatment of pancreas, kidney and brain cancer, will now be able to assist women combating advanced stage breast cancer.
The Food and Drug Administration (FDA) approved Afinitor on July 20, for use in combination with Aromasin to treat postmenopausal women with the advanced hormone-receptor HER2. The drug is aimed to be used following treatment with Femata or Arimidex.
In a clinical study comprised of 724 women with advanced stage breast cancer, researchers examined the duration of time a patient lived without her cancer advancing, or progression-free survival (PFS). All patients had menopause, estrogen receptor-positive, HER2 negative breast cancer that had already spread and had initial treatment with Femata or Arimidex.
One group of women received Afinitor with Aromasin, while another group of women received Aromasin with a placebo. Treatment continued until the cancer either advanced or side effects became intolerable.
Women who received Afinitor alongside Aromasin lived 4.6 months longer than the women who received the placebo alongside Aromasin.
According to Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, this is the first authorization of drugs known as mTOR inhibitors to treat postmenopausal women with the advanced stage breast cancer.
“Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval," he said.
Side effects that one may experience included: mouth ulcers, infections, rash, fatigue, diarrhea and decreased appetite. Women who are 65 years or older should be supervised thoroughly because they are at higher rate of serious side effects than younger women receiving the treatment.
According to breastcancer.org, one in eight women are expected to develop breast cancer during her lifetime. Last year alone 230,480 women were expected to be diagnosed with breast cancer and of those, 39,520 women would lose their battle with breast cancer.