The FDA has approved carfilzomib (Kyprolis) in combination with dexamethasone or with lenalidomide plus dexamethasone for patients with relapsed/refractory multiple myeloma following prior treatment with 1 to 3 lines of therapy, based on findings from the phase III ENDEAVOR trial.
Carfilzomib was previously approved in July 2015 in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received at least 1 to 3 prior lines of therapy, based on results from the phase III ASPIRE trial.
In the pivotal ASPIRE trial,2
the combination of carfilzomib, lenalidomide, and low-dose dexamethasone reduced the risk of progression by 31% compared with lenalidomide and low-dose dexamethasone alone in patients with relapsed multiple myeloma. The median PFS with carfilzomib was 26.3 months compared with 17.6 months without the proteasome inhibitor (HR, 0.69; 95% CI, 0.57-0.83; P
"Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet, and triplet combination that is offered in a variety of doses to meet individual patient needs," Sean E. Harper, MD, executive vice president of Research and Development at Amgen, the developer of carfilzomib, said in a statement. "Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer."
Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone (Kd) vs bortezomib and dexamethasone (Vd) in patients (pts) with relapsed multiple myeloma (RMM): results from the phase III study ENDEAVOR. J Clin Oncol. 2015;(suppl; abstr 8509).
Stewart KA, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone vs lenalidomide and dexamethasone in patients with relapsed multiple myeloma: interim results from ASPIRE, a randomized, open-label, multicenter phase 3 study. Presented at: 2014 ASH Annual Meeting; December 6-9, 2014, San Francisco, CA. Abstract: 79.