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/2018/103705s5453lbl.pdf. Revised April 2018. Accessed October 6, 2026.
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 adult patients with relapsed or refractory, low grade or follicular, CD20-positive B- cell NHL as a single agent. |
1 |
| 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. |
3 |
| RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL) non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. |
1 |
| RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL) previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. |
1 |
| RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL). |
1 |
Therapeutic response
Precision oncology relationships for therapeutic response derived from this document.
Organizations
Cancer types
| Organizations |
Biomarkers |
Cancer types |
Therapies |
|
|
FDA (1)
|
CD20 +
|
Non-Hodgkin Lymphoma |
Rituximab
|
|
|
FDA (1)
|
CD20 +
|
Non-Hodgkin Lymphoma |
Cyclophosphamide,
Prednisolone,
Rituximab,
Vincristine
|
|
|
FDA (1)
|
CD20 +
|
Non-Hodgkin Lymphoma |
Cyclophosphamide,
Doxorubicin,
Prednisolone,
Rituximab,
Vincristine
|
|
|
FDA (1)
|
CD20 +
|
Non-Hodgkin Lymphoma |
Cyclophosphamide,
Fludarabine,
Mitoxantrone,
Rituximab
|
|
|
FDA (2)
|
CD20 +
|
Non-Hodgkin Lymphoma |
Cyclophosphamide,
Doxorubicin,
Prednisone,
Rituximab,
Vincristine
|
|
|
FDA (1)
|
CD20 +
|
Chronic Lymphocytic Leukemia |
Cyclophosphamide,
Fludarabine,
Rituximab
|
|