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FDA approves Afinitor (everolimus) for breast cancer

(Reuters) – The U.S. Food and Drug Administration on Friday approved Novartis AG drug Afinitor (everolimus) to treat post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.

Afinitor is designed to be given in combination with another drug, Aromasin, to treat women whose cancer has recurred or progressed after treatment with two other therapies. Aromasin is made by Pfizer Inc.

A late-stage trial of 724 women showed those who received Aromasin plus Afinitor on average had 7.8 months before their cancer worsened, a 4.6 month improvement over people getting just Aromasin plus a placebo, the FDA said.

Afinitor is already approved to treat patients with four other types of cancer, including kidney and a rare type of pancreatic cancer. The European Medicines Agency in June also endorsed Afinitor as a breast cancer treatment.

“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, head of the FDA’s cancer drugs office.

“This approval redefines the treatment and management of advanced hormone receptor-positive breast cancer, offering a critical new option for physicians and patients,” said the co-lead investigator for the main Afinitor trial, Dr. Gabriel Hortobagyi, who is also a consultant for Novartis and chairman of Breast Medical Oncology at the University of Texas MD Anderson Cancer Center.