Monday, December 12, 2011

FDA won't give quick review to Onyx's multiple myeloma drug

Onyx Pharmaceuticals Inc. will have to wait in line for approval of its multiple myeloma drug — potentially adding weeks to the approval process — but reported results of another trial that ultimately could expand the treatment’s market.
South San Francisco-based Onyx (NASDAQ: ONXX) said the Food and Drug Administrated would review its new drug application for the drug, called carfilzomib, as it would any other drug. Onyx had sought accelerated approval based on a 266-patient Phase II trial.
What’s more, the FDA, which would complete its review by July 27, said in a letter to Onyx that its oncology drug advisory committee prefers Phase III trials. The agency also questioned whether carfilzomib’s benefit and risk are “appropriately balanced.”

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