Chemistry:Denileukin diftitox
| Clinical data | |
|---|---|
| Trade names | Ontak, others |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a611024 |
| License data | |
| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 70-80 min |
| Identifiers | |
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| CAS Number | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider |
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| UNII | |
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| Chemical and physical data | |
| Formula | C2560H4042N678O799S17 |
| Molar mass | 57647.46 g·mol−1 |
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Denileukin diftitox, sold under the brand name Ontak from 1999-2014, was an anti-cancer medication approved for the treatment of adults with T-cell lymphoma. It is an IL2-receptor-directed cytotoxin. It is an engineered protein combining interleukin-2 and diphtheria toxin.[3]
Medical uses
Denileukin diftitox was indicated for the treatment of adults with relapsed or refractory stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy.[1][2]
Adverse effects
The prescription label contains a boxed warning that capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in people receiving denileukin diftitox.[1][2]
Society and culture
Legal status
In 1999, denileukin diftitox was approved by the US Food and Drug Administration (FDA) for the treatment of cutaneous T-cell lymphoma.[1][4] It was voluntarily withdrawn from the market in 2014 due to manufacturing difficulties. Subsequently, a new formulation of deniluekin diftitox was developed (also known as E7777 or denileukin diftitox-cxdl) and approved in Japan in 2021 (marketed as Remitoro) and in the US in 2024 (marketed as Lymphir).[5]
References
- ↑ 1.0 1.1 1.2 1.3 "Ontak (denileukin diftitox) Injection for intravenous infusion Initial U.S. Approval: 1999". https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=246788.
- ↑ 2.0 2.1 2.2 fda.gov
- ↑ "Denileukin diftitox: a biotherapeutic paradigm shift in the treatment of lymphoid-derived disorders". Expert Review of Anticancer Therapy 7 (1): 11–17. January 2007. doi:10.1586/14737140.7.1.11. PMID 17187516.
- ↑ "Denileukin diftitox: a novel immunotoxin". Expert Opinion on Biological Therapy 9 (11): 1445–1451. November 2009. doi:10.1517/14712590903348135. PMID 19817678.
- ↑ "An evaluation of denileukin diftitox for the treatment of relapsed or refractory cutaneous T-cell lymphoma". Expert Opinion on Biological Therapy 25 (7): 687–694. July 2025. doi:10.1080/14712598.2025.2517853. PMID 40489974.
External links
- "Denileukin Diftitox (Code C1476)". https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C1476.
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