Amgen (AMGN) suffered a major setback when its phase III study, FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) on multiple myeloma treatment, Kyprolis did not meet its primary endpoint.
The open-label study evaluated Kyprolis versus an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients suffering from relapsed and advanced refractory multiple myeloma.
However, the study did not meet its primary endpoint of improving overall survival (:OS). The results from the study showed that there was an increase in the incidence of renal adverse events of all grades in the Kyprolis arm compared to the active control arm and the label.
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