Biologics License Application for CTCL Treatment Submitted to the FDA

By Leah Sherwood - Last Updated: November 23, 2022

A Biologics License Application was submitted to the U.S. Food and Drug Administration (FDA) by the manufacturer of the drug denileukin diftitox for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL).

Denileukin diftitox is an engineered interleukin (IL)-2 diphtheria toxin fusion protein that works by delivering a cytotoxic protein by binding to the IL-2 receptors found in malignant T-cells and immunosuppressive T-regulatory cells, according to the manufacturer.

Data from a phase III study assessing the treatment in patients with persistent or recurrent CTCL are being used to support the Biologics License Application. Results of the study were consistent with a prior FDA-approved formulation of the drug.

Source: Business Wire, September 2022

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