Regulatory approval

Published by the Food and Drug Administration. Approved

RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma (NHL) in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.

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 + Non-Hodgkin Lymphoma Cyclophosphamide, Prednisolone, Rituximab, Vincristine
FDA (2) CD20 + Non-Hodgkin Lymphoma Cyclophosphamide, Doxorubicin, Prednisolone, Rituximab, Vincristine
FDA (2) CD20 + Non-Hodgkin Lymphoma Cyclophosphamide, Fludarabine, Mitoxantrone, Rituximab

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2018-04-03 Food and Drug Administration Indication received traditional approval.