By david Liu PHD

Friday July 20, 2012 (foodconsumer.org) - The FDA announced today that it has approved a new treatment known as Afinitor or everolimus for advanced hormone receptor positive, HER2-negative breast cancer in postmenopausal women. The drug is intended to be used together with Aromasin (exemestance).

The drug marketed by East Hanover, N.J.-based Novartis Pharmaceuticals Corporation is intended for use in women with recurrence or progression of their breast cancer after receiving treatment with Femara (letrozole) or Arimidex )anastrozole).

Usually, patients with advanced cancer have poor prognosis because modern treatments often can't help them any more.  According to one physician,  the 5-year survival odds for patients with advanced cancer a few years ago were no more than 10%.

The safety and effectiveness of Afinitor was tested in a clinical trial of 724 patients with advanced breast cancer.  In the study, all patients had experienced menopause, had estrogen receptor-positive (ER+), HER2-negativebreast cancer that had spread and they all had received treatment with Demara or Arimidex.  Patients were treated with Afinitor until their cancers still progressed or side effects become unacceptable.

It was found that patients with Afinitor in a combination with Aromasin had lived for an extra 4.6 months without the cancer progressing, or progression-free survival (PFS), compared to patients receiving treatment with Aromasin alone.

"The most common side effects observed in patients receiving Afinitor for breast cancer were mouth ulcers, infections, rash, fatigue, diarrhea and decreased appetite," the FDA says.   Side effects were found more serious among patients older than 65 who the FDA says should be closely monitored.

Afinitor has been approved early "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," the FDA says in a press release.