Therapy Areas: Cardiovascular
CHMP Issues Positive Opinion Regarding Addition of Overall Survival Results from ASPIRE Study to Kyprolis (carfilzomib) Label
2 May 2018 - - The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion to Thousand Oaks, California-based human therapeutics developer Amgen (NASDAQ: AMGN) recommending a label variation for Kyprolis (carfilzomib) to include the final overall survival (OS) data from the Phase 3 ASPIRE trial, the company said.
The international, randomized Phase 3 ASPIRE trial evaluated Kyprolis in combination with lenalidomide and dexamethasone, versus lenalidomide and dexamethasone alone, in patients with relapsed or refractory multiple myeloma following treatment with one to three prior regimens.
ASPIRE demonstrated that the addition of Kyprolis to lenalidomide and dexamethasone reduced the risk of death by 21% versus lenalidomide and dexamethasone alone and extended OS by 7.9 months in patients with relapsed or refractory multiple myeloma..
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.
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