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FDA Updates Velcade (Bortezomib) Labeling to Include Retreatment in Patients with Multiple Myeloma
The FDA has approved Velcade (bortezomib, Millennium/Takeda) for the retreatment of adult patients with multiple myeloma who had responded to bortezomib therapy and had relapsed at least 6 months after the completion of prior bortezomib treatment.
The labeling update includes dosing guidelines as well as safety and efficacy findings for the use of bortezomib as a single agent or bortezomib in combination with dexamethasone in patients previously treated with bortezomib. Bortezomib retreatment may be started at the last tolerated dose.
The international phase II RETRIEVE trial showed a 38.5% overall response rate in patients with multiple myeloma who had been treated with a bortezomib-based regimen (a median of two prior lines of therapy) and had previously achieved a partial response or better. The safety profile seen with bortezomib retreatment was consistent with the known safety profile of intravenous bortezomib in relapsed multiple myeloma; no cumulative toxicities were observed during retreatment. The most common adverse reaction was thrombocytopenia, which occurred in 52% of the patients.
RETRIEVE was a single arm, open-label trial. The study enrolled 130 patients aged 18 years and older who had previously responded to bortezomib-based therapy and who had relapsed at least 6 months before treatment with bortezomib. The study met its primary endpoint of best confirmed response to retreatment, as assessed by European Group for Blood and Marrow Transplantation (EBMT) criteria.
Velcade (bortezomib) is approved for the treatment of patients with multiple myeloma. It is also indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior treatment.
Source: Millennium; August 8, 2014.