Multiple Myeloma

U.S. FDA accepts sNDA filing with priority review for VELCADE for myeloma

Published in Cancer Weekly, December 28th, 2004

Millennium Pharmaceuticals, Inc., (MLNM) announced the U.S. Food and Drug Administration (FDA) accepted for review the company's supplemental new drug application (sNDA) and granted priority review designation for VELCADE for the treatment of patients with multiple myeloma who have received at least one prior therapy.

The submission was based on data from the phase III APEX study that compared VELCADE to a traditional myeloma therapy, high-dose dexamethasone, which demonstrated a statistically significant survival in patients receiving VELCADE.

A patient population of approximately 22,000 in the U.S. could potentially benefit from a new second-line...

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Source: Cancer Weekly (2004-12-28)

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