UPDATE: Kyprolis for Injection Receives Accelerated Approval from FDA for Advanced Multiple Myeloma
Multiple Myeloma Research Foundation (MMRF) and Multiple Myeloma Research Consortium (MMRC) Played Integral Role in Clinical Development of First New Treatment for Multiple Myeloma in Five Years
The Multiple Myeloma Research Foundation (MMRF) today announced that its partner, Onyx Pharmaceuticals (NASDAQ: ONXX) received U.S. Food and Drug Administration (FDA) approval for Kyprolis™ (carfilzomib) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including Velcade (bortezomib) for Injection and an immunomodulatory agent, such as Thalomid (thalidomide) or Revlimid (lenalidomide), and have demonstrated disease progression on or within 60 days of completion of the last therapy. The approval of Kyprolis is based on response rate.
The MMRF's affiliate organization, the Multiple Myeloma Research Consortium (MMRC), a clinical trials network of 16 leading multiple myeloma centers in North America, has bolstered the clinical development of Kyprolis for the past six years, providing clinical trial support and resources, including driving accrual to the pivotal Phase IIb trial (003-A1) that supported the accelerated approval of the treatment.
“The approval of Kyprolis is an immensely important milestone for the multiple myeloma patient community, which continues to face significant unmet need in terms of safe and effective treatments for advanced disease. While we have seen tremendous progress in the past decade, multiple myeloma remains incurable,” stated Kathy Giusti, Founder and CEO of the MMRF and MMRC and a multiple myeloma patient. “We commend the FDA and Onyx for their dedication to enabling patient access to Kyprolis, and are proud of our long-term and continued partnership with Onyx throughout the development of this critical new treatment.”
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