Kyprolis sNDA Submitted for Expanded Relapsed Multiple Myeloma Indication
Amgen announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma, who has received at least one prior therapy.
The sNDA submission is based on data from the randomized, global Phase 3 ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsoneVs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial evaluating Kyprolis in combination with dexamethasone vs. Velcade with dexamethasone in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens. The primary endpoint of the trial was progression-free survival (PFS).
Relapsed multiple myeloma patients treated with Kyprolis and dexamethasone in the study lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade (median progression-free survival [PFS] 18.7 months vs. 9.4 months, HR=0.53, 95% CI: 0.44–0.65; P<0.0001).
Kyprolis is also being evaluated in the CLARION study, a head-to-head Phase 3 multicenter, open-label, randomized study in transplant-ineligible patients with newly diagnosed multiple myeloma. The study is evaluating the safety and efficacy of carfilzomib, melphalan and prednisone vs. bortezomib, melphalan and prednisone.
Kyprolis currently has accelerated approval for the treatment of patients with relapsed multiple myeloma as a monotherapy.
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