BRIEF—Ono Pharma files for supplemental approval of Kyprolis in Japan

Japanese drugmaker Ono Pharmaceutical has submitted a supplemental application of Kyprolis (carfilzomib), a proteasome inhibitor, in Japan for additional dosage and administration for the treatment of relapsed or refractory multiple myeloma, as a partial change in approved items of the manufacturing and marketing approval.

This application is based on the result from a global multiple-center, randomized, open-label Phase III study (ONO-7057-06/A.R.R.O.W. study), evaluating the efficacy and safety of Kyprolis in combination with dexamethasone, comparing Kyprolis 20/7 mg/m2 once-weekly dosing regimen versus Kyprolis 20/27mg/m2 twice-weekly regimen in patients with relapsed or refractory multiple myeloma.

Since Kyprolis was first approve for the treatment of patients with multiple myeloma in the USA in July 2012, about 80,000 patients worldwide have received the drug. As for the dosage and administration of Kyprolis 20/70mg/m2 once-weekly filed in Japan this time, it was approved in the USA in September 2018