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.
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