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). 

Great news for patients! The FDA has approved a once-weekly dosing option of carfilzomib (Kyprolis) to use in combination with dexamethasone for patients with relapsed/refractory multiple myeloma. Learn more: https://t.co/mT91aswj3F

— Multiple Myeloma RF (@theMMRF) October 1, 2018

Phase I/II study of once-weekly #Kyprolis, #Pomalyst, and low-dose dex for relapsed/refractory #myeloma finds ORR was 54% and median PFS was 10.3 months: https://t.co/lUbW7D4zlT. pic.twitter.com/t7kAw9IiET

— Robert Z. Orlowski (@Myeloma_Doc) October 1, 2018

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. 

Breaking news: @US_FDA approves a new dosing option for KYPROLIS® (carfilzomib). Learn more here: https://t.co/l6aJrTvYyl

— Amgen 🧪🔬🧬 (@Amgen) October 1, 2018

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