Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to rituximab in combination with fludarabine and cyclophosphamide for the treatment of previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL).

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 and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL).

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	CD20 +	Chronic Lymphocytic Leukemia	Cyclophosphamide, Fludarabine, 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.