FDA Approves New KYPROLIS® (SBECD-enabled carfilzomib) Combination Regimen With DARZALEX® (daratumumab) And Dexamethasone

Approval Based on the CANDOR and EQUULEUS Studies in Patients With Relapsed/Refractory Multiple Myeloma

Amgen today announced the U.S. Food and Drug Administration (FDA) has approved the expansion of the 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.

“This expanded approval for KYPROLIS demonstrates a leap forward in the treatment paradigm for this complex disease by combining two potent agents in their respective drug classes indicated for patients with relapsed or refractory multiple myeloma,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen.

Multiple myeloma is a blood cancer characterized by patterns of remission and relapse. Patient outcomes worsen with each relapse.¹ With the increasing use of frontline immunomodulatory drug based (IMiD) therapies through progression, the number of patients treated with these agents who will progress is likely to increase with time. This creates an emerging need for efficacious lMiD-free regimens upon relapse.² 

“Despite ongoing advances in the treatment of multiple myeloma, the disease remains incurable and is especially challenging for patients who relapse or become refractory to established therapies,” said Saad Z. Usmani, M.D., director of clinical research in hematologic malignancies; director of plasma cell disorders; clinical professor of medicine, Atrium Health’s Levine Cancer Institute. “As a clinician, having the DKd regimen as an option means we can now combine two efficacious, targeted agents in a new, immunomodulatory drug-free triplet regimen that has demonstrated deep and durable responses for patients upon relapse.”

Amgen has submitted marketing applications globally.

DARZALEX^® is a registered trademark of Janssen Pharmaceutica NV.