In January 2011, the FDA granted carfilzomib fast-track status, allowing Onyx to initiate a rolling submission of its new drug application for carfilzomib.[8] In December 2011, the FDA granted Onyx standard review designation,[9][10] for its new drug application submission based on the 003-A1 study, an open-label, single-arm phase 2b trial. The trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide.[11] It costs approximately $10,000 per 28-day cycle.[12]