FDA Approves Bortezomib Injection for Previously Untreated Patients With Mantle Cell Lymphoma

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The U.S. Food and Drug Administration (FDA) has approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma. This is the first treatment in the United States to be approved for use in previously untreated patients with mantle cell lymphoma. Bortezomib was previously approved for the treatment of relapsed or refractory mantle cell lymphoma in 2006.

Phase III Study

This approval is based on the results of an international, randomized, head-to-head phase III study that showed that previously untreated patients receiving a bortezomib-containing combination (VR-CAP; bortezomib, rituximab [Rituxan], cyclophosphamide, doxorubicin, and prednisone) experienced a 59% relative improvement in the study’s primary endpoint of progression-free survival compared to those who were administered the standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen (median, 25 vs 14 months; hazard ratio [HR] = 0.63; P < .001) at a median follow-up of 40 months. The complete response rate for patients receiving VR-CAP vs R-CHOP was 44% vs 34%.

The open-label, multicenter, prospective study evaluated the efficacy and safety of VR-CAP vs R-CHOP in 487 patients with previously untreated mantle cell lymphoma who were ineligible or not considered for a bone marrow transplant. Bortezomib (1.3 mg/m2) was administered intravenously in combination with intravenous rituximab, cyclophosphamide, doxorubicin, and oral prednisone for six 3-week treatment cycles. For patients with a response first documented at cycle 6, two additional VR-CAP cycles were ­recommended.

Adverse Reactions

The most common adverse reactions occurring in ≥ 20% of patients receiving the VR-CAP regimen were neutropenia, leukopenia, anemia, thrombocytopenia, lymphopenia, peripheral neuropathy, pyrexia, nausea, and diarrhea. Infections were reported for 31% of patients in the VR-CAP arm and 23% of the patients in the R-CHOP arm including pneumonia (8% vs 5%). Adverse reactions leading to discontinuation occurred in 8% of patients in the VR-CAP arm and 6% of patients in the R-CHOP arm. In the VR-CAP group, the most commonly reported adverse reaction leading to discontinuation was peripheral sensory neuropathy (1%). ■





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