Onyx initiates phase III comparison trial in relapsed multiple myeloma
Onyx Pharmaceuticals, a San Francisco-based global biopharmaceutical company, has begun enrollment in the ENDEAVOR trial, a phase III trial evaluating Kyprolis (proposed brand name for carfilzomib) in combination with dexamethasone, versus bortezomib (Velcade) with dexamethasone in patients with relapsed multiple myeloma.
"The ENDEAVOR trial is the first head-to-head trial conducted with Kyprolis, and is an important step in the development program," said Ted W. Love, M.D., executive vice president of R&D and technical operations, Onyx Pharmaceuticals. "The initiation of this trial underscores our commitment to patients with multiple myeloma who are in need of new treatment options beyond the currently available therapies."
The FDA is currently reviewing a New Drug Application (NDA) for potential accelerated approval of Kyprolis in the U.S. for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent (IMiD). The Prescription Drug User Fee Act (PDUFA) date for completion of the NDA review by the FDA is July 27, 2012.