Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
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.