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Roche’s Zelboraf Melanoma Drug Wins Backing of EU Regulator

Roche Holding AG (ROG)’s Zelboraf treatment for a specific type of melanoma was recommended for approval by the European Union’s drug regulator.

Zelboraf may be used on metastatic or unresectable melanoma, a form of the skin cancer with lower rates of survival than localized melanoma, the European Medicines Agency said in a statement today.

The drug, a so-called BRAF inhibitor that was cleared for sale in the U.S. in August, works by blocking a protein that fuels tumor growth in about half of patients with advanced forms of the skin cancer. Zelboraf would help treat a disease that kills 8,300 men and 7,600 women a year in Europe, according to the EMA.

“There is a high unmet medical need for alternative treatments for metastatic melanoma that improve survival of patients,” the London-based agency said. About 25 percent of patients diagnosed with metastic or unresectable melanoma survive a year after diagnosis, compared with 90 percent of patients with localized melanoma, it said.

The recommendation to approve Zelboraf “represents an important milestone for people with metastatic melanoma who until recently had limited treatment options,” Hal Barron, chief medical officer at Basel, Switzerland-based Roche, said in a statement. “We are working closely with health authorities worldwide to bring Zelboraf to people with this deadly disease as soon as possible.”

BRAF-Inhibitor Work

Zelboraf was developed by Roche and Plexxikon Inc., which was acquired this year by Tokyo-based Daiichi Sankyo Co. (4568) Other companies working on BRAF inhibitors include Amgen Inc. (AMGN), GlaxoSmithKline Plc (GSK), Novartis AG (NOVN) and Pfizer Inc. (PFE), according to the Bloomberg drug database.

The agency’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 region.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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