Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to rituximab for the treatment of adult patients with non-progressing (including stable disease), low-grade, CD20 positive, B-cell Non-Hodgkin's Lymphoma (NHL) as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

This is written in the approval document as:

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.

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.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) CD20 + Non-Hodgkin Lymphoma Cyclophosphamide, Doxorubicin, Prednisone, Rituximab, Vincristine