FDA approves addition of updated survival data and hepatic dosing to Velcade label

Millennium Pharmaceuticals announced that the FDA has approved an expanded label for Velcade (bortezomib) that includes long-term overall survival (OS) data from the VISTA trial as well as dosing recommendations for patients with hepatic impairment. VISTA, a Phase 3, multicenter, international trial evaluated Velcade-based therapy in patients with previously untreated multiple myeloma who were not eligible for stem cell transplantation (median follow-up 36.7 months). The primary endpoint of the trial was time-to-disease progression, with secondary endpoints including overall survival, progression-free survival, response rates, and safety.

The long-term follow-up data demonstrated that patients treated with Velcade, melphalan and prednisone (VcMP) continued to have significantly longer OS than those treated with melphalan and prednisone (MP) alone (p=0.0008). These results translated into a 35% reduction in risk of death. The OS benefit of VcMP was observed despite the use of subsequent therapies at relapse, including Velcade based regimens.

Velcade is indicated for the treatment of multiple myeloma as well as mantle cell lymphoma in patients who have received at least one prior therapy.

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