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FDA Expands Velcade (Bortezomib) Label to Include Previously Untreated Patients With Mantle Cell Lymphoma

Drug previously OK’d for relapsed or refractory disease
The FDA has given the nod to bortezomib for injection (Velcade, Millenium/Takeda) for use in previously untreated patients with mantle cell lymphoma (MCL). Bortezomib is the first treatment approved in the U.S. for previously untreated MCL; the medication was approved for use in relapsed or refractory MCL in 2006.

“Mantle cell lymphoma is a subtype of non-Hodgkin lymphoma that is usually a clinically aggressive malignancy, and it is a challenging disease to treat in part due to a relatively high risk of relapse,” said Andrew Evens, DO, MSc, Director of the Tufts Cancer Center, Chief of the Division of Hematology/Oncology, and Director of the Lymphoma Program.

“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,” Evens said. “Velcade, when used in the VcR-CAP regimen — Velcade, rituximab, cyclophosphamide, doxorubicin, and prednisone — has demonstrated improved outcomes for patients.”

The new approval is based on the results of an international, randomized, head-to-head phase III study showing that previously untreated patients receiving the VcR-CAP combination 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 PFS, 25 versus 14 months; hazard ratio [HR] 0.63; P

The open-label, multicenter, prospective study evaluated the efficacy and safety of VcR-CAP versus R-CHOP in 487 patients with previously untreated MCL who were ineligible or not considered for a bone marrow transplant. Velcade (1.3 mg/m2) is administered intravenously in combination with intravenous rituximab, cyclophosphamide, doxorubicin, and oral prednisone for six 3-week treatment cycles.

Velcade is administered first, followed by rituximab. Velcade is administered twice weekly for two weeks (days 1, 4, 8, and 11), followed by a 10-day rest period on days 12–21. For patients with a response first documented at cycle 6, two additional VcR-CAP cycles are recommended. At least 72 hours should elapse between consecutive doses of Velcade.

The most common adverse reactions occurring in at least 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. In the VcR-CAP group, the most commonly reported adverse reaction leading to discontinuation was peripheral sensory neuropathy (1%; three patients).

MCL is a rare, aggressive type of B-cell non-Hodgkin lymphoma (NHL) that usually occurs in older adults.

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