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Carfilzomib Works Well As Salvage Treatment; Momentum Builds For Frontline Role

This article was originally published in The Pink Sheet Daily

Executive Summary

Small study of Onyx' proteasome inhibitor shows potential for replacing Velcade in combination with Revlimid and dexamethasone in newly diagnosed multiple myeloma patients.

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

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.

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

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.

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

FDA has expressed preference for having multiple confirmatory trials in the works to support an accelerated approval application.

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