BORTEZOMIB APPROVED FOR MCL

The US Food and Drug Administration (FDA) today approved bortezomib (Velcade; Millennium) for previously untreated patients with mantle cell lymphoma (MCL).

The indication is an extension of the injectable drug's labeling, as bortezomib is already approved for patients with relapsed/refractory MCL, as well as for the treatment for multiple myeloma.

The new approval is based on the results of an open-label, randomized, phase 3 clinical trial of 487 previously untreated patients with MCL that compared a bortezomib-containing combination with a standard regimen.

The patients were either ineligible or not considered for a bone marrow transplant.

In the trial, the VcR-CAP (Velcade, rituximab, cyclophosphamide, doxorubicin, and prednisone) regimen improved progression-free survival by 11 months compared with the standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen (25 vs 14 months; hazard ratio [HR], 0.63; P < .001). The median follow-up was 40 months.

That translated into a 59% relative improvement in progression-free survival, the study's primary endpoint, which was assessed by an independent review committee.

The complete response rate for patients receiving VcR-CAP vs R-CHOP was 44% vs 34%.

The most common adverse reactions occurring in 20% or more of patients receiving the VcR-CAP regimen were neutropenia, leukopenia, anemia, thrombocytopenia, lymphopenia, peripheral neuropathy, pyrexia, nausea, and diarrhea.

Infections were reported in 31% of patients in the VcR-CAP group and 23% of the patients in the R-CHOP group and included pneumonia (8% vs 5%).

Adverse reactions leading to discontinuation occurred in 8% of patients in the VcR-CAP group and 6% of patients in the R-CHOP group.

"There are several new targeted drugs approved by the FDA for patients with relapsed or refractory disease, but up to this point, there had been none approved for the treatment of patients with previously untreated disease," said Andrew Evens, DO, director, Tufts Cancer Center in Boston, Massachusetts, in a press statement.