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Millennium Pharmaceuticals, Inc.

FDA grants full approval for VELCADE (bortezomib) for injection

Published in Lab Business Week, May 8th, 2005

Millennium Pharmaceuticals, Inc., (MLNM) announced the U.S. Food and Drug Administration (FDA) approved the company's supplemental new drug application for VELCADE.

This approval expands the label to include the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy. VELCADE is the only drug therapy that has demonstrated a significant survival advantage as compared to a standard therapy in relapsed MM, according to the company. Initial accelerated approval for relapsed and refractory MM was granted in May 2003. VELCADE is now fully approved in relapsed MM.

The approval was based on data from the randomized phase...

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