Amgen : FDA Approves New KYPROLIS For Multiple Myeloma

(RTTNews) - Amgen (AMGN) said that the U.S. Food and Drug Administration has approved the expansion of the KYPROLIS or carfilzomib U.S. prescribing information to include its use in combination with DARZALEX or daratumumab plus dexamethasone or DKd in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.

The expansion of KYPROLIS's prescribing information to include once-weekly dosing of KYPROLIS within the DKd regimen was supported by the open-label, multi-cohort Phase 1b EQUULEUS trial, in which the safety and efficacy of DKd was assessed among R/R MM patients using a once-weekly dosing regimen for KYPROLIS.

Multiple myeloma is a blood cancer characterized by patterns of remission and relapse. Patient outcomes worsen with each relapse.

Amgen has submitted marketing applications globally.

DARZALEX is a registered trademark of Janssen Pharmaceutica NV.