Rituxan (rituximab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

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 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
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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	CD20 +	Non-Hodgkin Lymphoma	Rituximab
Sensitivity (+)	CD20 +	Non-Hodgkin Lymphoma	Cyclophosphamide, Prednisolone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Non-Hodgkin Lymphoma	Cyclophosphamide, Doxorubicin, Prednisolone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Non-Hodgkin Lymphoma	Cyclophosphamide, Fludarabine, Mitoxantrone, Rituximab
Sensitivity (+)	CD20 +	Non-Hodgkin Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Non-Hodgkin Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Diffuse Large B-Cell Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Burkitt Lymphoma	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Mature B-Cell Neoplasms	Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine
Sensitivity (+)	CD20 +	Chronic Lymphocytic Leukemia	Cyclophosphamide, Fludarabine, Rituximab