Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

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 +	Diffuse Large B-Cell Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Burkitt Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Mature B-Cell Neoplasms	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine