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Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Date:4/26/2012

SOUTH SAN FRANCISCO, April 26, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's new drug application (NDA) for carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies. ODAC will review carfilzomib at its meeting on June 20, 2012. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA is July 27, 2012.

"Multiple myeloma is a deadly disease for which there are no cures, and we are committed to bringing carfilzomib to patients as quickly as possible," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "Our team looks forward to discussing the potential efficacy benefit and safety profile of carfilzomib with the advisory committee and will continue to work closely with the FDA during its review."

About Oncologic Drugs Advisory Committee
The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to FDA. 

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 Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical
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SOURCE Onyx Pharmaceuticals, Inc.
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