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Onyx Pharmaceuticals Announces Plans to Amend Phase 3 FOCUS Study for European Registration
Date:3/28/2011

le myeloma following treatment with at least three prior therapies.  Patients are being randomized to receive carfilzomib (20mg/m2 on days 1 and 2 of cycle 1 only, then 27mg/m2 subsequently).   The primary endpoint is overall survival with secondary endpoints including PFS, overall response rate (ORR), clinical benefit rate (CBR) and duration of response (DOR), as well as safety.  The study design incorporates planned interim analyses on the primary endpoint.

Onyx on Track for Submission of NDA in the U.S.  

In January, Onyx announced that the U.S. Food and Drug Administration (FDA) had granted fast track designation for carfilzomib.  Onyx has initiated a rolling submission of a New Drug Application (NDA) for potential accelerated approval of carfilzomib in the U.S. Through the Fast Track designation, Onyx is eligible to submit the carfilzomib NDA on a rolling basis, allowing Onyx to begin the NDA filing process immediately and giving the FDA an opportunity to review the completed sections of the registration application. Onyx has now submitted the non-clinical section of the carfilzomib NDA with the FDA and commenced its rolling NDA process. Onyx intends to complete its submission of the NDA for potential accelerated approval of carfilzomib in the U.S. as early as mid-2011.

About the Carfilzomib Development Program

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.  Carfilzomib is also being evaluated in a broad investigator sponsored tria
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SOURCE Onyx Pharmaceuticals, Inc.
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