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 Non-Hodgkin Lymphoma.
The U.S. Food and Drug Administration granted approval to rituximab in combination with CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy regimens for the treatment of adult patients with previously untreated diffuse large B-cell, CD20-positive Non-Hodgkin's Lymphoma (NHL). This indication is based on three randomized, active-controlled, open-label, multicenter studies with a collective enrolled of 1854 patients. The product label did not specify the name of the clinical trial name (Study 9) that administered an anthracycline-containing chemotherapy regimen, or what the specific regimen was.
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 adult patients with Non-Hodgkin's Lymphoma (NHL) previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.