FDA Approves Bortezomib for Patients with Previously Untreated Mantle Cell LymphomaPosted: October 13, 2014
Late last week the FDA announced the approval of bortezomib (VELCADE) for injection for patients with previously untreated mantle cell lymphoma (MCL). This approval was based on results from a head to head Phase III clinical trial. The study found that,
“…previously untreated patients receiving a VELCADE-containing combination (VcR-CAP) experienced a 59 percent relative improvement in the study’s primary endpoint of progression-free survival (PFS) 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<0.001) at a median follow up of 40 months. An Independent Review Committee (IRC) assessed the primary efficacy endpoint of PFS. The complete response (CR) rate for patients receiving VcR-CAP vs. R-CHOP was 44 percent vs. 34 percent.”
The full press release can be found here.
The full listing of MCL trials at WCMC is available on the clinical trials website. Look to this space for further news concerning bortezomib trials for MCL patients at WCMC.