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Velcade gains new indication

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Millenium Pharmaceutical's oncologic Velcade (bortezomib) is approved for mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, the company announces Dec. 8. MCL is a relatively uncommon and aggressive subtype of non-Hodgkins lymphoma for which there is no cure in the relapsed or refractory setting. The condition has a U.S. prevalence of 10,000 patients. The approval was based on the company's Phase II PINNACLE trial, a single-arm, open-label study that enrolled 155 patients and showed an overall response rate of 31%. Velcade is currently the market leader in multiple myeloma for patients who have received one prior therapy. The drug is being codeveloped with Johnson & Johnson...

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