Denileukin diftitox

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Denileukin diftitox
Clinical data
Trade namesOntak
Routes of
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life70-80 min
  • Diphtheria toxin-Interleukin-2 fusion protein
CAS Number
  • none
Chemical and physical data
Molar mass57647.46 g·mol−1
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Denileukin diftitox (trade name Ontak) was an antineoplastic agent, an engineered protein combining interleukin-2 and diphtheria toxin. Denileukin diftitox could 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]

There is some evidence tying it to vision loss, and in 2006 the FDA added a black box warning to the drug's label.[3]

In 2014, marketing of Ontak was discontinued in the US.[4]


  1. ^ Turturro F (January 2007). "Denileukin diftitox: a biotherapeutic paradigm shift in the treatment of lymphoid-derived disorders". Expert Review of Anticancer Therapy. 7 (1): 11–7. doi:10.1586/14737140.7.1.11. PMID 17187516. S2CID 9028829.
  2. ^ Manoukian G, Hagemeister F (November 2009). "Denileukin diftitox: a novel immunotoxin". Expert Opinion on Biological Therapy. 9 (11): 1445–51. doi:10.1517/14712590903348135. PMID 19817678. S2CID 23956460.
  3. ^ Lansigan F, Stearns DM, Foss F (February 2010). "Role of denileukin diftitox in the treatment of persistent or recurrent cutaneous T-cell lymphoma". Cancer Management and Research. 2: 53–9. doi:10.2147/cmar.s5009. PMC 3004568. PMID 21188096.
  4. ^ "FDA Drug Shortages". U.S. Food and Drug Administration. 31 January 2014. Retrieved 3 July 2017.

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