WASHINGTON — The Food and Drug Administration has cleared Novartis' drug Afinitor for a new use in women with advanced breast cancer that has not responded to two other drugs.
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The pill-based drug is already approved to treat 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," said Dr. Richard Pazdur, director of the FDA's cancer drug office.
On Friday the drug was approved for use in combination with Aromasin for postmenopausal women with recurring HER2-negative breast cancer, after treatment with the drugs Femara and Arimidex. HER2 is a protein that is overproduced in about one-fourth of all breast cancers. Afinitor is approved for breast cancers that are not caused by the protein.
Novartis studied Afinitor in a study of 724 patients who randomly received either Afinitor plus the breast cancer drug Aromasin or a placebo plus Aromasin. Patients who received the two-drug combination lived about 4.6 months longer without seeing their disease progress.
The most common side effects reported in the trial were mouth ulcers, infections, fatigue and diarrhea.
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