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# FDA Approves Amgen sNDA for Survival Data
- URL: https://www.fdaweb.com/fda-approves-amgen-snda-for-survival-data/
- Published: 2018-06-11T12:00:00.000Z
- Updated: 2026-09-15T00:12:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141650

FDA has approved an Amgen supplemental NDA to add positive overall survival data from the Phase 3 ASPIRE trial to the prescribing information for Kyprolis (carfilzomib). The new data show that Kyprolis, lenalidomide and dexamethasone significantly reduced the risk of death by 21% and extended overall survival by 7.9 months versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma, according to the company. Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells, Amgen says, and in some cells, like myeloma cells, it causes cell dealth because they are more likely to contain a higher amount of abnormal proteins.