Novartis Wins U.S. Approval for Afinitor in Breast Cancer

Novartis AG (NOVN) won U.S. approval to market its cancer drug Afinitor for breast tumors, an achievement that may add more than $1 billion in annual sales.

Afinitor was cleared for breast cancer patients whose disease has spread after earlier treatment, and who lack the so- called HER2 gene, the Food and Drug Administration said in a statement today. The drug is already approved in the U.S. to treat cancers of the kidney and pancreas and a type of non- cancerous brain tumor. European regulators recommended approving Afinitor for breast cancer last month.

The approval gives Basel, Switzerland-based Novartis a drug for a type of breast cancer that strikes about 30,000 women in the U.S. each year. Sales of the drug in that disease alone may add “well above $1 billion” in sales, David Epstein, head of the company’s pharmaceutical division, said on a call with analysts yesterday.

“Take-off should be relatively quick for the product,” Epstein said on the call.

Sales of Afinitor climbed 66 percent to $318 million in the first half, Novartis said in its earnings report.

In a trial among 724 women whose disease had progressed after hormone therapy, Afinitor delayed the progression of breast cancer by a median of 7.8 months when combined with Pfizer Inc.’s Aromasin, compared with 3.2 months among patients receiving Aromasin alone, according to data presented at a cancer conference in May. The trial was stopped early because it was working so well.

Twenty-five percent of those receiving the combination had died after 18 months, compared with 32 percent of patients receiving Aromasin alone, the company said.

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To contact the editor responsible for this story: Phil Serafino at

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