The approval extends the use of bortezomib beyond relapsed and refractory patients.
The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the FDA has approved VELCADE® (bortezomib) for injection for use in previously untreated patients with mantle cell lymphoma (MCL). VELCADE is the first treatment in the United States to be approved for use in previously untreated patients with MCL. This approval extends the utility of VELCADE beyond relapsed or refractory mantle cell lymphoma, for which it has been approved since 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, Tufts Cancer Center; chief, Division of Hematology/Oncology; director, 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. VELCADE, when used in the VcR-CAP regimen, VELCADE, rituximab, cyclophosphamide, doxorubicin and prednisone, has demonstrated improved outcomes for patients, making it an important advance for the treatment of newly-diagnosed patients with mantle cell lymphoma.”
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