A supplemental new drug application has been filed with the FDA and a variation to the marketing application has been filed with the European Medicines Agency by Amgen for Kyprolis, or carfilzomib. The applications will include late-stage trial data in which a combination of Kyprolis and dexamethasone reduced risk of death by 21% and increased overall survival by 7.6 months compared with velcade and dexamethasone.
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