Regulatory approval

Published by the Food and Drug Administration. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	CD20 +	Diffuse Large B-Cell Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
FDA (2)	CD20 +	Burkitt Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
FDA (2)	CD20 +	Mature B-Cell Neoplasms	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2021-12-02	Food and Drug Administration	Indication received traditional approval.