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FDA Approves Carfilzomib Label Update in Myeloma

Jason M. Broderick @jasoncology
Published: Wednesday, Jan 17, 2018

The FDA has approved a supplemental new drug application that adds overall survival (OS) data from the phase III ENDEAVOR trial to the label for carfilzomib (Kyprolis) for use in patients with relapsed or 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 [published online August 23, 2017]. Lancet Oncol. doi: 10.1016/ S1470-2045(17)30578-8.

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