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Onyx Pharmaceuticals Announces Data Presentations Highlighting Carfilzomib at 53rd American Society of Hematology Annual Meeting
Date:11/7/2011

pany has an agreement with the FDA on a Special Protocol Assessment (SPA) on the design and planned analysis of the ASPIRE trial.
  • A Phase 3 clinical trial, called the FOCUS trial to support registration in Europe, is evaluating single-agent carfilzomib in patients with relapsed and refractory myeloma who have received three or more prior therapies.
  • A Phase 2 clinical trial, known as the 004 study, is evaluating single-agent carfilzomib in patients with relapsed and/or refractory multiple myeloma who have received one to three prior therapies.
  • A Phase 1b/2 study, known as the 006 study, is evaluating carfilzomib in combination with lenalidomide and low dose dexamethasone in patients with relapsed and/or refractory myeloma.
  • A Multiple Myeloma Research Consortium (MMRC) Phase 1/2 study is evaluating carfilzomib in combination with lenalidomide and low dose dexamethasone in newly diagnosed patients. This study is supported by Onyx Pharmaceuticals, MMRC, and Celgene Corporation.
  • A Phase 1/2 study being conducted by Onyx's partner Ono Pharmaceutical Co., Ltd is evaluating carfilzomib in Japanese patients with relapsed/refractory multiple myeloma.
  • An expanded access program is underway in partnership with the Multiple Myeloma Research Foundation for eligible patients in the U.S., with relapsed and refractory multiple myeloma for whom no satisfactory treatment alternatives are available.

  • 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.(1) Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually.(2)

    About Onyx Pharmaceuticals, Inc.
    Based in South San Francisco
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    SOURCE Onyx Pharmaceuticals, Inc.
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