Everolimus Approved for Treating Some Breast Cancers || NCI Cancer Bulletin for August 7, 2012 - National Cancer Institute

NCI Cancer Bulletin for August 7, 2012 - National Cancer Institute
Everolimus Approved for Treating Some Breast Cancers

Everolimus Approved for Treating Some Breast Cancers

The Food and Drug Administration (FDA) has approved the drug everolimus (Afinitor) in combination with exemestane (Aromasin) to treat certain postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.

The treatment is intended for women whose disease has progressed after treatment with letrozole (Femara) or anastrozole (Arimidex), according to a July 20 FDA news release.

Everolimus is also approved for treating some patients with advanced renal cell carcinoma, progressive advanced pancreatic neuroendocrine tumors, or the benign brain tumor called subependymal giant cell astrocytoma.

The new approval was based on a clinical trial that showed a 4.6-month improvement in median time to disease progression or death in women who received everolimus and exemestane compared with women who received exemestane and a placebo.

Everolimus prevents cell proliferation and the formation of tumor blood vessels by inhibiting the mammalian target of rapamycin (mTOR) signaling pathway.

The most common side effects in patients receiving everolimus for breast cancer were mouth ulcers, infections, rash, fatigue, diarrhea, and decreased appetite. The FDA cautioned that patients who are aged 65 and older should be monitored closely because they are more likely to have more serious side effects than younger patients.