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Onyx Pharmaceuticals Submits New Drug Application for Carfilzomib in Relapsed and Refractory Multiple Myeloma
Date:9/28/2011

progression within 60 days after completion of therapy.(i) The primary endpoint was overall response rate. Secondary endpoints included duration of response, clinical benefit rate, overall survival, time-to-progression, progression-free survival, and safety. Safety data from additional carfilzomib studies were also included in the submission.

Carfilzomib Development Program

Carfilzomib is being studied in several additional trials either as a single-agent or in combination with other therapies, including:

  • A Phase 3 clinical trial, known as the ASPIRE trial, is evaluating the combination of lenalidomide and low dose dexamethasone with or without carfilzomib in patients with relapsed multiple myeloma who have received one to three prior therapies. The company 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 greater than three 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, 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 at the University of Michigan Comprehensive Cancer Center, evaluating carfilzomib in combination of lenalidomide and low dose dexamethasone in newly diagnosed patients. This study is sponsored by Onyx Pharmaceuticals, MMRC, Celgene Corporation and the University of Michigan Comprehensive Cancer Center.
  • A Phase 1/2 study being conducted
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SOURCE Onyx Pharmaceuticals, Inc.
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