Denileukin diftitox

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Denileukin diftitox
Clinical data
Trade names Ontak
AHFS/ Monograph
MedlinePlus a611024
  • US: C (Risk not ruled out)
Routes of
ATC code
Legal status
Legal status
Pharmacokinetic data
Biological half-life 70-80 min
CAS Number
  • none
Chemical and physical data
Formula C2560H4042N678O799S17
Molar mass 57647.3 g/mol
 NYesY (what is this?)  (verify)

Denileukin diftitox (trade name Ontak) is an antineoplastic agent, an engineered protein combining Interleukin-2 and Diphtheria toxin. This can bind to Interleukin-2 receptors[1] and introduce the diphtheria toxin into cells that express those receptors, killing the cells. In some Leukemias and Lymphomas malignant cells express these receptors, so denileukin diftitox can target these.

In 1999 Ontak was approved by the U.S. Food and Drug Administration (FDA) for treatment of Cutaneous T-cell lymphoma (CTCL).[2]

A recent study at the University of Louisville found the drug caused many stage IV cutaneous T-cell lympomas to regress or stabilize extending patient life expectancy from about eight months to more than a year; a clinically significant increase especially given the guarded prognosis of patients with advanced disseminated cutaneous T-cell lymphoma (CTCL) and the generally poor response to other available treatments.

There is some evidence tying it to vision loss and in 2006 the FDA added a black box warning to the drug's label.[2]


  1. ^ Turturro F (2007). "Denileukin diftitox: a biotherapeutic paradigm shift in the treatment of lymphoid-derived disorders". Expert Rev Anticancer Ther. 7 (1): 11–7. doi:10.1586/14737140.7.1.11. PMID 17187516. 
  2. ^ a b FDA Page Last Updated: May 11, 2009 Changes in the Ontak (denileukin diftitiox) Package Insert to Include a Description of Ophthalmologic Adverse Events

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