The Food and Drug Administration (FDA) has approved Kyprolis (carfilzomib; Onyx) injection in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received 1–3 prior lines of therapy.  

RELATED: Kyprolis sNDA Submitted for Expanded Relapsed Multiple Myeloma Indication

The FDA approval was based on results from a multi-center, open-label trial that enrolled 792 patients with relapsed or refractory multiple myeloma after 1-3 lines of prior therapy. Patients were randomized to lenalidomide and dexamethasone with or without carfilzomib for 18 cycles. Results showed a statistically significant prolongation of progression-free survival (HR 0.69; 95% CI: 0.57, 0.83; P<0.0001). Median progression-free survival was higher in the 3-drug arm vs. the 2-drug arm (26.3 months vs. 17.6 months). A treatment effect was seen across all subgroups tested. In an interim analysis, a partial response or better was achieved by 87% of patients in the 3-drug arm and 67% on the 2-drug arm. 

The labeling also includes new Warnings and Precautions for venous thromboembolism, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension

Kyprolis is available as a 60mg strength in single-dose vials.

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