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

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.