Bloomberg News

Novartis’s Afinitor Wins Initial EU Clearance for New Use

June 22, 2012

Novartis AG (NOVN)’s Afinitor treatment was recommended for an additional indication for breast cancer by the European Union’s drug regulator.

Afinitor may be used for post-menopausal women with the HER2 receptor gene in combination with the generic drug exemestane, the London-based European Medicines Agency said in a statement today.

The treatment is approved in the U.S. and Europe for cancers of the kidney and pancreas, and in the U.S. for non- cancerous brain tumors. Approval for the drug in breast cancer could add more than $1 billion to annual sales, Basel, Switzerland-based Novartis has said.

In a trial among 724 women whose cancer had progressed after hormone therapy, 25 percent of those receiving a combination of Afinitor and Pfizer Inc. (PFE:US)’s Aromasin had died after 18 months, compared with 32 percent of patients receiving Aromasin plus a placebo, Novartis said on May 31.

The regulator’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 27-nation bloc. The commission usually accepts the agency’s advice.

To contact the reporter on this story: Makiko Kitamura in London at

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

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