Annotation of U.S. Food and Drug Administration (FDA) label information
for denileukin diftitox
and IL2RA
Summary
The FDA-approved drug label for denileukin diftitox (Ontak) notes that it is indicated for patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor. Confirmation of malignant cells expressing CD25 is necessary prior to administration of the drug.
Annotation
Denileukin diftitox (Ontak) is indicated for patients with persistent or recurrent cutaneous T-cell lymphoma. The FDA-approved drug label for denileukin diftitox states that confirmation that a patient's malignant cells express CD25 is necessary prior to beginning treatment with the drug.
Excerpts from the denileukin diftitox (Ontak) label:
Ontak is a CD25-directed cytotoxin indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor.
CD25 Tumor Expression and Evaluation...Confirm that the patient's malignant cells express CD25 prior to administration of Ontak. A testing service for the assay of CD25 expression in tumor biopsy samples is available.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the denileukin diftitox drug label.
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