FDA Approves New Drug for Late-Stage Breast Cancer

A new drug has been approved for advanced breast cancer patients whose disease is not responding to two other drugs.

Afinitor is already used on various tumors of the pancreas, kidney, and brain.

"Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval," Dr. Richard Pazdur said.

The drug was approved to be used in combination with Aromasin for women in post-menopause who have recurring HER2-negative breast cancer. This can be given after they receive treatment with drugs Femara and Arimidex.

Protein HER2 is overproduced in 1/4 of all breast cancers. Afinitor can be used on those who have breast cancer that is not caused by the protein.

The drug's manufacturer, Novartis, studied it with 724 patients. The patients received either Afinitor plus the other breast cancer drug Aromasin, or a placebo plus Aromasin. Those who received Afinitor and Aromasin lived 4.6 months longer without disease progression.

Afinitor's most common side effects are mouth ulcers, infections, fatigue an diarrhea.