SOUTH SAN FRANCISCO, Calif., June 20, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) determined by a vote of 11-0 [with 1 abstention] 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 (IMiD), the benefit-risk assessment is favorable for the use of Kyprolis™ (proposed brand name for carfilzomib). Onyx is developing Kyprolis for use in multiple myeloma across a variety of treatment lines.
"Today's ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "Onyx is committed to bringing Kyprolis to patients as quickly as possible and looks forward to working closely with the FDA as the agency completes its review."
The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Kyprolis NDA for accelerated approval is July 27, 2012. The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.
The Kyprolis NDA is based on the 003-A1 study, an open-label, single-arm Phase 2b trial as well as supportive data from additional studies. The 003-A1 trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.Conference Call Details Onyx's management team will host a webcast and conference call to discuss the ODAC recommendations. The call will be held today, June 20 at 7:00 p.m. Eastern Time ( 4:00 p.m. Pacific Time). To access a live audio webcast of the conference call, log onto the company's website at: http://www.onyx.com/investors/event-calendar To access the live conference call on June 20, 2012, dial (847) 585-4405 and use the passcode 32594605. A replay of the call will be available on the Onyx website or by dialing (630) 652-3042 and using the passcode 3259 4605# approximately two hours after the conference call concludes through July 4, 2012. About Multiple Myeloma Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually.(i) Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually.(ii) About the Kyprolis™ (proposed brand name for carfilzomib) Development Program Kyprolis is an investigational agent and is not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other health authorities.
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