Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

Citation

Genentech, Inc. Rituxan (rituximab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5467lbl.pdf. Revised December 2021. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	CD20 +	Non-Hodgkin Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Non-Hodgkin Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine