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Millennium Velcade Supplement Seeks Full Approval, Second-Line Use

This article was originally published in The Pink Sheet Daily

Executive Summary

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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Velcade Phase III Studies Will Support First-Line Use, Millennium Says

The company expects to initiate three Phase III studies to support full approval of Velcade for treatment of multiple myeloma. FDA grants priority review designation to Velcade sNDA for second-line use, Millennium announces.

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