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Onyx Pharmaceuticals Receives Fast Track Designation for Carfilzomib; Company Initiates Rolling NDA Submission for Accelerated Approval
Date:1/31/2011

eloma. We are committed to making carfilzomib available to these very ill patients as quickly as possible."

Carfilzomib was granted orphan drug designation by the FDA for the treatment of multiple myeloma in 2008.  Orphan drug designation is granted to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Under the designation, the sponsor may be eligible for grant funding towards clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following drug approval by the FDA.

About the Carfilzomib Development Program

Carfilzomib is a selective, next generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma.  

The carfilzomib development program includes a large, randomized international Phase 3 clinical trial, known as the ASPIRE trial, studying the combination of lenalidomide and low dose dexamethasone with or without carfilzomib in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial. A second Phase 3 clinical trial, called the FOCUS trial, is evaluating carfilzomib in patients with relapsed and refractory myeloma in Europe. Carfilzomib is also being evaluated in a broad investigator sponsored trial program including 1st line multiple myeloma, combination studies, lymphoma and other malignancies.

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 ann
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SOURCE Onyx Pharmaceuticals, Inc.
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