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Subcutaneous Velcade Gains FDA Nod
The FDA nod is for all approved indications of Velcade — multiple myeloma and mantle cell lymphoma after at least one prior therapy, the company said.
The approval was based on results from a randomized Phase 3 trial in 222 patients with relapsed multiple myeloma who had not previously taken Velcade. The primary goal of the trial was to show that single-agent subcutaneous Velcade retained at least 60 percent of the overall response rate after four cycles compared to single-agent intravenous drug administration. The secondary endpoints of the study included safety and tolerability, time to progression, progression-free survival and one-year overall survival.
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