Enrollment complete for Phase III Carfilzomib (Onyx Pharmaceuticals) trial for Multiple Myeloma

The Phase III ASPIRE trial evaluating carfilzomib, from Onyx Pharmaceuticals, in combination with Revlimid (lenalidomide) and low dose dexamethasone in patients with relapsed Multiple Myeloma has reached its target enrollment figures of 780 patients and is being conducted at approximately 200 sites in North America, Europe, and Israel. The FDA is currently reviewing a New Drug Application for potential accelerated approval of carfilzomib in the US 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. In addition to ASPIRE, carfilzomib is currently being studied in several clinical trials either as a single-agent or in combination with other therapies, including the Phase III FOCUS trial evaluating single-agent carfilzomib in patients with relapsed and refractory Myeloma who have received three or more prior therapies.