FDA approved bortezomib (Velcade) injection for previously untreated patients with mantle cell lymphoma.
The 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 (bortezomib, rituximab [Rituxan], cyclophosphamide, doxorubicin, and prednisone) experienced a 59 percent relative improvement in the study’s primary endpoint of progression-free survival (HR=0.63; p < .001)
The open-label prospective study evaluated 487 patients with previously untreated mantle cell lymphoma who were ineligible or not considered for a bone marrow transplant.
Patients in the bortezomib arm had a median PFS of 25 months, compared to 14 months in patients who received the standard R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) at a median follow-up of 40 months. The complete response rate for patients receiving the bortezomib combination compared to R-CHOP was 44 vs. 34 percent.
Bortezomib was previously approved for the treatment of relapsed or refractory mantle cell lymphoma in 2006.
