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

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine. Patients with multiple myeloma who have become refractory—or resistant—to the drugs Revlimid® (lenalidomide) and Velcade have limited treatment options. There is no standard treatment for these patients and they typically have a poor prognosis, with a median overall survival of 9 months.

The FDA approval for retreatment was largely based on the Phase 2 international RETRIEVE trial. RETRIEVE was a single arm, open-label clinical trial that enrolled 130 patients ages 18 years and older who had previously responded to Velcade-based therapy and relapsed at least six months after prior treatment with Velcade. Patients had received a median of two prior therapies (range of 1-7).

Overall 38.5 percent of multiple myeloma patients who had been previously treated with a Velcade-based regimen responded to retreatment with Velcade. Importantly the safety profile seen with Velcade retreatment was consistent with the known safety profile of intravenous Velcade in relapsed multiple myeloma and no additional cumulative toxicities were observed upon retreatment.

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