Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to rituximab 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 indication is based on 3 randomized, controlled trials that enrolled 1,662 patients where patients received either CVP (cyclophosphamide, vincristine, and prednisolone), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), or FCM (cyclophosphamide, fludarabine, mitoxantrone).

This is written in the approval document as:

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.

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.

Therapeutic response

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

Contributions