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Amgen files application in Europe for expanded use of Kyprolis

2015-12-06 03:02:21| Biotech - Topix.net

Amgen submits a Variation to the Marketing Authorization Application to the European Medicines Agency seeking clearance for the use of Kyprolis , in combination with the corticosteroid dexamethasone, in adult multiple myeloma patients who have received at least one prior therapy. The data supporting the application was generated in the Phase 3 ENDEAVOR study that showed patients treated with Kyprolis plus dexamethasone achieved superior progression-free survival compared to patients who received Takeda's Velcade plus dexamethasone were diarrhea, anemia, fatigue, dyspnea , pyrexia and insomnia.

Tags: of application files europe

Category:Biotechnology and Pharmaceuticals

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