David M. Reese, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended adding final overall survival (OS) data from the phase III ASPIRE trial to the label for carfilzomib (Kyprolis) for the treatment of patients with relapsed/refractory multiple myeloma.
Hypertension (17.1% vs 8.7%) and venous thrombotic events (10.2% vs 6.2%) occurred more often with carfilzomib. Otherwise, the incidence of acute renal failure, cardiac failure, ischemic heart disease, and peripheral neuropathy occurred in a similar proportion of patients in both groups. The most common grade ≥3 special interest AE was hypertension (6.4% with carfilzomib). No other grade ≥3 special-interest event occurred in as many as 5% of patients.
- Stewart AK, Siegel D, Ludwig H, et al. Overall survival (OS) of patients with relapsed/refractory multiple myeloma (RRMM) treated with carfilzomib, lenalidomide, and dexamethasone (Krd) versus lenalidomide and dexamethasone (Rd): Final analysis from the randomized phase 3 ASPIRE trial. Presented at: American Society of Hematology 59th Annual meeting; December 9-12, 2017; Atlanta, GA. Abstract 743.
- Dimopoulos MA, Goldschmidt H, Niesvizky R, et al. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial [published online August 23, 2017]. Lancet Oncol. doi: 10.1016/ S1470-2045(17)30578-8.
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