Millennium Gets Priority Review for Velcade

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Millennium’s Velcade was granted priority review from the FDA for patients with newly diagnosed multiple myeloma (MM). The sNDA for this indication included data from the Phase III VISTA study, a large, international trial, comparing a Velcade based regimen to a traditional standard of care. Priority review is granted for a treatment that addresses an unmet medical need and demonstrates an improvement over existing therapies. The FDA expedites the approval process for these applications from ...

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