Onyx stated that carfilzomib data makes it a suitable candidate for accelerated approval in the relapsed and refractory treatment setting. The company expects a decision from the FDA in the next few weeks regarding a priority or standard review.
Carfilzomib achieved an overall response rate, which is a partial response or greater, of 24.1 percent and a median duration of response of 7.8 months in 003-A1 study, an open-label, single-arm Phase 2b trial. The median overall survival for all patients in the study, regardless of response to drug, was 15.6 months.
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