Enrollment complete in Onyx Phase 3 ASPIRE trial for relapsed multiple myeloma

Feb 23 2012

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that it has reached the target enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone in patients with relapsed multiple myeloma.  The company has an agreement with the U.S. Food and Drug Administration (FDA) for a Special Protocol Assessment (SPA) and has received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial.

"The ASPIRE trial, which is designed to support full approval of carfilzomib for patients with relapsed multiple myeloma, is an important component of our overall regulatory strategy to bring carfilzomib to the broadest number of patients in need of new treatment options," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development and Technical Operations at Onyx Pharmaceuticals. "We are pleased to have enrollment in the ASPIRE study ahead of schedule, and could have interim results as early as the first half of 2013."

The FDA is currently reviewing a New Drug Application (NDA) for potential accelerated approval of carfilzomib in the U.S. for the treatment of patients with relapsed and refractory multiple myeloma. The Prescription Drug User Fee Act (PDUFA) date for completion of the NDA review by the FDA is July 27, 2012.