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Onyx’s Kyprolis Sails Through FDA Panel, Boosted By Confirmatory Trial Plans

This article was originally published in The Pink Sheet Daily

Executive Summary

The Oncologic Drugs Advisory Committee overwhelmingly concluded that carfilzomib has a positive risk/benefit assessment in relapsed/refractory myeloma. Onyx’s fully enrolled Phase III confirmatory trial, and the company’s plans for a second study that will commence soon, gave the committee confidence in recommending accelerated approval despite the limitations of a single-arm study.

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