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Onyx Files Carfilzomib For Accelerated Approval With Two Phase III Trials Ongoing

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

With two Phase III trials already in progress, Onyx Pharmaceuticals Inc. looks well-positioned for an FDA accelerated approval of its proteasome inhibitor carfilzomib in relapsed and refractory multiple myeloma – and if accelerated approval is not granted, it should have data to resubmit roughly a year later.

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