Velcade "Impressive" Efficacy Offsets Concern Over Response As Endpoint
This article was originally published in The Pink Sheet Daily
Millennium’s multiple myeloma agent response rate is "better than expected," NDA review documents indicate. FDA reverses its initial request for Phase III study results to support accelerated approval after final data from Phase II are submitted.
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The company hopes to convert Velcade's accelerated approval for third-line use to full approval and add a second-line multiple myeloma indication based on the Phase III APEX trial, which showed a significant survival benefit.
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