Bloomberg News

Onyx Rejected by U.S. in Request for Faster Cancer-Drug Review

December 13, 2011

Dec. 11 (Bloomberg) -- Onyx Pharmaceuticals Inc.’s experimental cancer drug carfilzomib will get a standard review from U.S. regulators, instead of an accelerated process sought by the company.

The Food and Drug Administration said the South San Francisco, California-based company hadn’t conducted the clinical trials necessary for the quicker review of carfilzomib, Onyx said today in a statement.

The FDA scheduled a target date of July 27, four months later than under an accelerated approval, to decide whether to approve carfilzomib for patents with multiple myeloma, a cancer of plasma cells, Onyx said in its statement. The company, which developed Nexavar for kidney cancer, submitted its application in September.

“Our goal remains to make this promising new therapy available to patients with relapsed and refractory multiple myeloma as quickly as possible,” Ted Love, Onyx’s executive vice president of research and development, said in the statement.

Carfilzomib may generate $227.6 million in sales by the end of 2014, according to the average estimate of four analysts surveyed by Bloomberg.

--Editor: Andrew Pollack

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net -0- Dec/12/2011 02:05 GMT


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