In July 2012, carfilzomib was given accelerated approval by the Food and Drug Administration for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior therapies including bortezomib and an immunomodulatory agent and have exhibited disease progression during or within 60 days of completing their last therapy. The approval was based on results of a single-arm, multicenter phase 2 trial of carfilzomib in patients with relapsed and refractory MM. As a condition of the accelerated approval, the manufacturer of the drug has to submit a final analysis of an ongoing phase 3 trial that compares carfilzomib plus lenalidomide plus low-dose dexamethasone with lenalidomide plus low-dose dexamethasone in patients with relapsed and refractory MM after 1 to 3 previous therapies. The primary end point of this trial is progression-free survival (PFS)...
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