Posted by Michael Wonder on 12 Jun 2018
FDA approves addition of positive overall survival data from Phase 3 ASPIRE trial to Kyprolis (carfilzomib) label
11 June 2018 - Kyprolis, lenalidomide and dexamethasone extended median overall survival in relapsed or refractory multiple myeloma patients to 48 months.
Amgen today announced that the U.S. FDA has approved the supplemental new drug application to add the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for Kyprolis (carfilzomib).
Data added to the label showed that Kyprolis, lenalidomide and dexamethasone (KRd) significantly reduced the risk of death by 21% and extended overall survival by 7.9 months versus lenalidomide and dexamethasone alone (Rd) in patients with relapsed or refractory multiple myeloma (median OS 48.3 months for KRd versus 40.4 months for Rd, HR=0.79, 95% CI, 0.67 – 0.95; two-sided p=0.0091).
