FDA approves bortezomib for injection for previously untreated patients with mantle cell lymphoma

FDA approved bortezomib (Velcade, Millennium: The Takeda Oncology Company) for injection for use in previously untreated patients with mantle cell lymphoma (MCL), making it the first treatment in the United States to be approved for previously untreated patients with MCL.

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“It’s important for formulary managers at hospitals and managed care organizations to know that this FDA approval means that patients with previously untreated mantle cell lymphoma can be prescribed Velcade treatment to help manage their disease,” said Dixie-Lee Esseltine, MD, FRCPC, vice president, Oncology Clinical Research, Takeda Pharmaceuticals International Co.

This approval extends the utility of Velcade beyond relapsed or refractory mantle cell lymphoma, for which it has been approved since 2006.

It is important to manage MCL because although it is a rare subtype of non-Hodgkin lymphoma (constitutes about 6% of non-Hodgkin's lymphoma cases), it is aggressive, has a poor prognosis and usually occurs in older adults, according to Dr Esseltine. 

The disease typically begins in the lymph nodes but can spread to other tissues, such as bone marrow and liver. The expected overall survival for MCL is approximately 4 to 5 years, and the 5-year survival rate for advanced stage MCL is approximately 50%.

This 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 end point 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<.001) at a median follow up of 40 months. An Independent Review Committee (IRC) assessed the primary efficacy end point of PFS. The complete response (CR) rate for patients receiving VcR-CAP vs. R-CHOP was 44% vs. 34%.

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