FDA Approves Carfilzomib in Combination with Dexamethasone for Multiple Myeloma Patients

The Food and Drug Administration (FDA) approved once-weekly carfilzomib in combination with dexamethasone to treat relapsed and refractory multiple myeloma. 

The FDA’s expanded approval follows a randomized, open-label, phase 3 A.R.R.O.W. trial of patients aged ≥ 18 years with relapsed and refracted multiple myeloma who had already underwent two or three treatments. Patients were randomly assigned to receive carfilzomib either once a week (70 mg/m2) (n = 240) or twice a week (27 mg/m2) (n = 238), and all patients also received dexamethasone. The once a week group intravenously received carfilzomib (30 min) on days 1, 8, and 15 of all cycles (20 mg/m2 day 1 [cycle 1]; 70 mg/m2 thereafter). The twice a week group received carfilzomib intravenously for 10 minutes on days 1, 2, 8, 9, 15, and 16 (20 mg/m2 days 1 and 2 during cycle 1; 27 mg/m2 thereafter). 

The once a week group had higher median progression-free survival rates compared to the twice a week group (11.2 months [95% CI 8.6–13.0] vs 7.6 months [5.8–9.2]; hazard ratio [HR] 0.69, 95% CI 0.54–0.83; p = 0.0029). Once weekly patients were less likely to experience grade 3 or worse cardiac failure (3% [n = 7] vs 4% [n = 10]). Grade 3 or worse adverse events occurred more frequently among the once weekly group than the twice weekly group (68% [n = 161] vs 62% [n = 145]), the most common of which were anemia, pneumonia, and thrombocytopenia (18% [n = 42] vs 18% [n = 42], 10% [n = 24] vs 7% [n = 16], and 7% [n = 17] vs 7% [n = 16], respectively for once weekly carfilzomib vs twice weekly carfilzomib). The once weekly and twice weekly groups saw 58 and 68 deaths, respectively, at the time of data cutoff. 

Carfilzomib, marketed under the name Kyprolis, is manufactured by Amgen. The FDA first approved the drug in 2012. 

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Sources: Healio, The Lancet