Rituxan (rituximab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Genentech, Inc. Rituxan (rituximab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf. Revised December 2021. Accessed October 6, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) CD20 + Diffuse Large B-Cell Lymphoma Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
FDA (1) CD20 + Burkitt Lymphoma Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
FDA (1) CD20 + Mature B-Cell Neoplasms Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine