Millennium announced that the Food and Drug Administration (FDA) has approved Velcade (bortezomib) for the retreatment of adult patients with multiple myeloma (MM) who had previously responded to Velcade therapy and relapsed at least six months following completion of prior Velcade treatment.

The update now includes dosing guidelines as well as safety and efficacy results for the use of Velcade as a single agent or as combination therapy with dexamethasone in patients previously treated with Velcade. Velcade retreatment may be started at the last tolerate dose.

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The approved supplemental New Drug Application (sNDA) was supported by a Phase 2 single arm, open-label and other clinical data. The Phase 2 RETRIEVE trial demonstrated a 38.5% overall response rate (ORR) in MM patients who had been previously treated with a Velcade-based regimen and had previously achieved a partial response or better. Also, retreatment with Velcade showed the same safety profile as intravenous Velcade in relapsed MM with no cumulative toxicities.

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