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Safety Concerns Weigh On Onyx’s Carfilzomib In Multiple Myeloma

This article was originally published in The Pink Sheet Daily

Executive Summary

In briefing documents released ahead of the Oncologic Drugs Advisory Committee’s June 20 review, FDA cites concerns about severe toxicities with the proteasome inhibitor and the limitations of a single-arm trial. With an overall response rate of “only” 22%, carfilzomib may not provide an advantage over available therapies in the relapsed/refractory setting, review documents state.

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