Novartis AG 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.