The US Food and Drug Administration (FDA) have approved the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for injection in combination with dexamethasone (or with lenalidomide plus dexamethasone). The indication is for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The approval also states Kyprolis as a single agent treatment too.

Amgen, the manufacturer, first gain accelerated approval for Kyprolis in July 2012 as a single agent. Last July the FDA expanded its indication for use in combination with lenalidomide and dexamethasone.

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The latest approval is supported by results from the Phase 3 head-to-head ENDEAVOR study — a randomized, open label, superiority trial. The trial’s endpoint was progression free survival (PFS), which was demonstrated by those treated with Kyprolis and dexamethasone achieving a 50% greater PFS; 18.7 months, than those who received Velcade (bortezomib) and dexamethasone; 9.4 months (HR=0.53; 95 percent CI: 044, 0.65 p<0.0001).

“This FDA approval is important because it provides physicians with flexible options for Kyprolis use in helping to manage this challenging disease,” said Dr. Ruben Niesvizky, director of the Multiple Myeloma Center at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center.

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