August 20, 2020

Today, the U.S. Food and Drug Administration (FDA) “approved the expansion of Kyprolis® (carfilzomib) U.S. prescribing information to include its use in combination with Darzalex® (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy.”

IMF Chief Medical Officer Joseph Mikhael, MD, said, "This is an important approval for myeloma patients. The combination uses two potent myeloma agents from separate classes together early in relapsed myeloma. As most patients relapse when on lenalidomide maintenance therapy, carfilzomib plus daratumumab can overcome lenalidomide resistance in a conveniently delivered and continuous manner to keep patients in remission. The two dosing strategies of weekly, or twice-weekly carfilzomib, allow for flexibility for patients.”

This approval was based on the results of the phase III CANDOR trial and the phase 1b EQUULEUS trial.

Read the press release


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