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ASCO In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Velcade sNDA perches on a PINNACLE: Mantle cell lymphoma (MCL) could be the next indication for Millennium/J&J's Velcade (bortezomib), based on data from the PINNACLE study of relapsed or refractory patients with MCL, an aggressive subtype of non-Hodgkin's lymphoma. The firms announced the submission of an sNDA for treatment of relapsed or refractory MCL June 9. Millennium presented the pivotal Phase II PINNACLE trial at the American Society of Clinical Oncology meeting in Atlanta June 2-6. The single-arm trial enrolled 155 patients treated with at least two prior therapies. Patients received Velcade alone twice weekly for two weeks every 21 days for up to one year. Velcade patients demonstrated a 33% response rate and an 8% complete response rate; the median duration of response was 9.2 months, and 13.5 months in patients achieving a complete response. On the primary endpoint of time to progression, patients with a complete response had a median TTP of 19.3 months; median TTP overall was 6.2 months...

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