Despite entreaties from the company, Onyx Pharmaceuticals' oncology drug product carfilzomib will not be given an accelerated review by the US Food & Drug Administration.
Onyx submitted their application in September and sought accelerated review. Instead, US regulators have scheduled a target date of July 27, 2012 to review carfilzomib, which Onyx is seeking approval for in patients with relapsed or refractory multiple myeloma.
According to the FDA, Onyx has not completed the appropriate clinical trials to warrant accelerated approval. Onyx most recently got Nexavar to market, a treatment for kidney cancer.
Multiple myeloma is a cancer of the plasma cells within the bone marrow. According to SEER statistics, about 20,500 men and women in the US will be diagnosed with this cancer each year. Median age of diagnosis is 69, and median age at death is 74.
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