FDA approves updated indication for Velcade in Multiple Myeloma - Takeda

The FDA has approved Velcade (bortezomib), from Takeda, 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 labeling update includes dosing guidelines as well as safety and efficacy findings for the use of Velcade as a single agent or Velcade in combination with dexamethasone in patients previously treated with Velcade. Velcade retreatment may be started at the last tolerated dose.

The approved retreatment sNDA consisted of a Phase II study and other supportive data. The Phase II international RETRIEVE trial showed a 38.5 percent overall response rate (ORR) in multiple myeloma patients who had been previously treated with a VELCADE-based regimen (median of two prior lines of therapy) and had previously achieved a partial response or better. The safety profile seen with VELCADE retreatment was consistent with the known safety profile of intravenous VELCADE in relapsed multiple myeloma; no cumulative toxicities were observed upon retreatment. The most common adverse drug reaction was thrombocytopenia, which occurred in 52 percent of the patients.