FDA approves bortezomib (Velcade) for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy

On December 8, 2006, the U.S. Food and Drug Administration granted approval to bortezomib (VELCADE, Millennium Pharmaceuticals, Inc.), a proteasome inhibitor, for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

An open-label, single-arm, multicenter study of 155 patients with progressive mantle cell lymphoma who had received at least one prior therapy was performed to assess response rate and duration.  Seventy-five percent had one or more extra-nodal disease sites and 77% were stage 4.  In 91% of patients, prior therapy included an anthracycline or mitoxantrone, cyclophosphamide, and rituximab.  Thirty-seven percent were refractory to their last prior therapy.  Patients received bortezomib,1.3 mg/m2 intravenously, on days 1, 4, 8, and 11 of each 3 week cycle.

Response rates were determined according to the International Workshop Response Criteria (1999) and were based on an independent radiologic CT scan review.  The overall response rate (CR plus CRu plus PR) was 31% and the median response duration was 9.3 months.  The CR plus CRu response rate was 8% and the median response duration was 15.4 months.  The median number of cycles in responding patients was 8.  The median time to response was 40 days (range 31 to 204 days).

Adverse events, irrespective of their relationship to bortezomib, were similar to those observed in the previously reported myeloma studies (see product labeling).  The most commonly reported treatment-emergent adverse events were asthenic conditions (72%), peripheral neuropathies (55%), constipation (50%), diarrhea (47%), nausea (44%), and appetite decreased (39%).  The most common adverse event leading to discontinuation was peripheral neuropathy.

For safe use of bortezomib, patients must be kept well hydrated.  Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at www.fda.gov/cder/foi/label/2006/021602s010lbl.pdf.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088; by facsimile 1-800-FDA-0178 by mail using the Form 3500 at http://www.fda.gov/medwatch.index.html.

For further information related to oncology drug approvals, regulatory information, and other oncology resources, please refer to the FDA “Oncology Tools” website at www.fda.gov/cder/cancer.

PDF requires the free Adobe Acrobat Reader