FDA Approves New Dosing Option for Kyprolis in Multiple Myeloma

The approval was based on data from the Phase 3 A.R.R.O.W. trial.
The approval was based on data from the Phase 3 A.R.R.O.W. trial.

For patients with relapsed or refractory multiple myeloma, the Food and Drug Administration (FDA) has expanded the dosing options for Kyprolis (carfilzomib; Amgen) to include once-weekly administration in combination with dexamethasone.

The approval was based on data from the Phase 3 A.R.R.O.W. trial (N=478), which demonstrated that Kyprolis 70mg/m2 once-weekly plus dexamethasone achieved superior progression-free survival (PFS) compared with Kyprolis 27mg/m2 twice-weekly with dexamethasone (median PFS: 11.2 months vs 7.6 months; hazard ratio [HR] 0.69; 95% CI, 0.54-0.88; one-sided P=.0014). In addition, overall response rate was 62.9% for patients in the once-weekly group vs 40.8% for patients in the twice-weekly arm (P<.0001). With regard to adverse events, both regimens were found to have similar safety profiles with no new risks observed in the once-weekly treatment group. Kyprolis 27mg/m2 twice-weekly plus dexamethasone alone has not been approved by the FDA.

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"The availability of a more convenient once-weekly dosing regimen, with superior efficacy, comparable safety, and longer duration of therapy versus the twice-weekly regimen studied in the trial could allow patients to spend more time outside of the infusion center," said David S. Siegel, MD, PhD, chief of the Division of Multiple Myeloma at John Theuer Cancer Center at Hackensack University Medical Center.

Kyprolis, a proteasome inhibitor, is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy. It is also approved for use as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥1 lines of therapy.

For more information visit Amgen.com.