KYPROLIS, DARZALEX Combo Approved for Multiple Myeloma

Amgen received approval from the FDA for the expansion of KYPROLIS (carfilzomib) to include its use in combination with Janssen's 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 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.

"The DKd regimen provides an important potent triplet option in the setting of relapse following IMiD combination frontline therapy," said Brian G.M. Durie, M.D., chairman, International Myeloma Foundation.

The Phase 3 CANDOR trial was the first Phase 3 randomized trial to compare DKd versus KYPROLIS and dexamethasone (Kd) alone in R/R MM patients. The study met its primary endpoint and resulted in a 37% reduction in the risk of disease progression or death in patients receiving DKd compared to Kd alone.