FDA to Review Kyprolis sNDA for Relapsed Multiple Myeloma
Amgen announced that the Food and Drug Administration (FDA) has accepted for priority review the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma. The sNDA is designed to expand the current indication to include Kyprolis in combination with dexamethasone for patients who have received at least one prior therapy.
The sNDA is based on data from the Phase 3 ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsoneVs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) study, which included patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens. The primary endpoint was PFS, defined as the time from treatment initiation to disease progression or death.
The study showed that patients with relapsed multiple myeloma treated with Kyprolis and low-dose dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over bortezomib and low-dose dexamethasone (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, a proteasome inhibitor, received FDA approval in July 2015 as a combination therapy with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received 1–3 prior therapies.
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