Dec 12 2011
Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that the U.S. Food and Drug Administration (FDA) has granted Standard Review designation to the New Drug Application (NDA) for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the NDA is July 27, 2012.
In the NDA filing designation letter from the FDA, received December 9th, the agency advised the company that recent Oncology Drug Advisory Committee recommendations specify a preference for Phase 3 trials for the accelerated approval pathway. Based on its preliminary review and ongoing assessment of the application, the FDA outlined potential review issues including whether the application is sufficient to support an FDA conclusion that the data provided within the NDA meets accelerated approval criteria and whether the benefit and risk are appropriately balanced, given that the application is based on a single-arm study.
"Our goal remains to make this promising new therapy available to patients with relapsed and refractory multiple myeloma as quickly as possible," said Ted W. Love, M.D., executive vice president, research and development and technical operations at Onyx Pharmaceuticals. "We are committed to working with the agency to address the comments outlined in the letter."
SOURCE Onyx Pharmaceuticals, Inc.
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