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.
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.
Kyprolis is available as a 60mg strength in single-dose vials.
For more information call (877) 669-9121 or visit Kyprolis.com.