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Velcade gains mantle cell claim

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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 percent. 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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