Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that CD20 + status confers therapeutic sensitivity to Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine in patients with Burkitt Lymphoma.
The U.S. Food and Drug Administration granted approval to rituximab in combination with chemotherapy for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced state, CD20-positive: diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). This indication is based on three randomized, active-controlled, open-label, multicenter studies with a collective enrollment of 1854 patients where patients received either CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy regimens.
This statement is based on a regulatory approval from the Food and Drug Administration:
RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy.