FDA approves Novartis’ Afinitor for certain breast cancers

Hannah Blake

pharmaphorum

The US FDA has approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.

Breast cancer is the second leading cause of cancer-related death among women. The approval of Afinitor gives more treatment options to patients, as it is intended for use in women with recurrence or progression of their cancer after treatment with Femara or Arimidex.

A clinical study of 724 patients with advanced breast cancer evaluated the safety and effectiveness of Afinitor. 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.

“This is the first approval from the class of drugs known as mTOR inhibitors for the treatment of postmenopausal women with advanced homeone-receptor positive breast cancer. Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval.”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA has also accelerated approval of Onyx Pharmaceuticals’ multiple myeloma drug, Kyprolis. In a clinical trial with no control group, Kyprolis significantly shrank tumors in 23% of patients who had relapsed after receiving at least two previous therapies.