Onyx Pharmaceuticals, Inc. (ONXX) announced that the U.S. Food and Drug Administration's or FDA's Oncologic Drugs Advisory Committee or ODAC determined by a vote of 11-0 that, in patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent, the benefit-risk assessment is favorable for the use of Kyprolis.
Onyx stated that it is developing Kyprolis for use in multiple myeloma across a variety of treatment lines.
The Prescription Drug User Fee Act date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012.
Kyprolis is an investigational agent and is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or EMA or other health authorities.
The company said a new drug application or NDA for Kyprolis for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies is currently being reviewed by the U.S. FDA, and the anticipated date for completion of review is July 27, 2012.
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