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FDA Accepts sNDA for Carfilzomib Label Update in Myeloma

Jason M. Broderick @jasoncology
Published: Thursday, Aug 31, 2017

Robert Orlowski, MD, PhD

Robert Orlowski, MD, PhD
The FDA has accepted a supplemental new drug application (sNDA) seeking to add 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.

Adverse events observed in this updated analysis were consistent with those previously reported for ENDEAVOR. Investigators noted that rates of grade ≥2 peripheral neuropathy were five-times higher in patients assigned to bortezomib (35% vs 7%).

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