This additional approval is based on the result from a global multiple-center, randomized, openlabel Phase 3 study (ONO-7057-06/A.R.R.O.W. study), evaluating the efficacy and safety of Kyprolis in combination with dexamethasone, comparing Kyprolis 20/70 mg/m2 once-weekly dosing regimen (Kd70) versus Kyprolis 20/27 mg/m2 twice-weekly regimen (Kd27) in patients with relapsed or refractory multiple myeloma. In the result of interim analysis of progression-free survival (PFS), a primary endpoint, the median PFS was 11.2 months in the Kd70 arm versus 7.6 months in the Kd27 arm, demonstrating a statistically significant improvement (Hazard ratio: 0.69; 95% confidence interval: 0.54 - 0.88). The most frequently reported adverse events (20%) reported in either treatment regimen were anemia, diarrhea, fatigue, hypertension, insomnia and pyrexia.
The supplemental approval allows Kyprolis to expand its dosage and administration in combination with dexamethasone at a dosage of 20 mg/m2 only on Day 1 in Cycle 1, then escalating to 70 mg/m2 once-weekly thereafter. Kyprolis has been required so far to be administered twice-weekly under the previously approved dosage and administration, but the additional approval allows Kyprolis to be administered once-weekly leading to superior convenience.
Multiple myeloma is a blood cancer caused by an abnormality of plasma cells in the bone marrow. It is reported that there are nearly 25,000 patients in
About Kyprolis
Kyprolis is a highly selective proteasome inhibitor. Proteasome, an intra-cellular enzyme complex, functions to mediate degradation of polyubiquitinated proteins and control proliferation and differentiation of cells, as well as functional cell-death. Kyprolis inhibits certain proteasome activity, thereby inducing functional cell-death of myeloma. In
In
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