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# Amgen Gets Superiority Data Approved for Kyprolis Label
- URL: https://www.fdaweb.com/amgen-gets-superiority-data-approved-for-kyprolis-label/
- Published: 2018-01-17T12:00:00.000Z
- Updated: 2026-09-14T23:14:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140527

FDA has approved an Amgen supplemental NDA to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the prescribing information for Kyprolis (carfilzomib). The data demonstrated that Kyprolis and dexamethasone reduced the risk of death by 21% and increased OS by 7.6 months versus Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory multiple myeloma.

“Blood cancer therapies approved by the FDA between 2003 and 2013 only improved overall survival by an average of 2.61 months,” Amgen says. “Kyprolis and dexamethasone improved overall survival by 7.6 months, underscoring that this regimen is a significant advancement and should be considered a standard of care for patients with relapsed or refractory multiple myeloma.”