Millennium: The Takeda Oncology Company announced that the Food and Drug Administration (FDA) has approved Velcade (bortezomib) for the treatment of mantle cell lymphoma (MCL) in previously untreated patients.

The approval is based on the results of an international, randomized, head-to-head Phase 3 study that showed that previously untreated patients receiving a Velcade-containing combination (VcR-CAP) experienced a 59% 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; HR 0.63; P<0.001) at a median follow up of 40 months. The complete response (CR) rate for patients receiving VcR-CAP vs. R-CHOP was 44% vs. 34%.

Velcade is already indicated for multiple myeloma and in mantle cell lymphoma in patients who have received at least one prior therapy.

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This article originally appeared on MPR