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FDA OKs inclusion of additional overall survival data to Amgen's Kyprolis label

Amgen's supplemental new drug application for the addition of overall survival data to the label of relapsed or refractory multiple myeloma drug Kyprolis, or carfilzomib, was approved by the FDA. The data were from the late-stage ASPIRE study in which the drug, combined with lenalidomide and dexamethasone, significantly reduced the death risk of patients by 21% and extended overall survival by 7.9 months compared with lenalidomide and dexamethasone alone.

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