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EMA Panel Backs Carfilzomib Label Update in Myeloma

Jason Harris
Published: Tuesday, Jan 30, 2018

David M. Reese, MD

David M. Reese, MD
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a label variation for carfilzomib (Kyprolis) in patients with relapsed/refractory multiple myeloma.

Twenty-seven patients (6%) in the carfilzomib arm experienced grade ≥3 cardiac failure versus 9 patients (2%) in the bortezomib group. Six percent of patients assigned to carfilzomib and 3% of those assigned to bortezomib experienced grade ≥3 acute renal failure.
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. Lancet Oncol. 2017;18:1327-1337. doi: 10.1016/ S1470-2045(17)30578-8.

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