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Denileukin diftitox (Lymphir) is an infusion that uses the interleukin-2 signal as a homing device to deliver a bacterial toxin into cutaneous T-cell lymphoma cells. It was withdrawn in 2014 and returned in an improved form in 2024.
The original denileukin diftitox (Ontak) was approved in 1999 for persistent or recurrent CD25-positive cutaneous T-cell lymphoma and withdrawn from the US market in 2014 because of manufacturing problems. A reformulated, higher-purity product was approved by the FDA in August 2024 as Lymphir for adults with relapsed or refractory stage I to III CTCL after at least one systemic therapy, on Study 302, an open-label single-arm trial in which 36% of patients responded (with CD25 expression on at least 20% of malignant cells required for entry). Capillary leak syndrome, infusion reactions and visual changes carry boxed warnings and require premedication and close monitoring.
Fusion of interleukin-2 with diphtheria toxin fragments A and B; binds CD25-expressing cells, is internalised, and the toxin blocks protein synthesis and kills the cell. Connects to CD25 (IL-2 receptor alpha).
1.Denileukin diftitox's antibody arm binds CD25 (IL-2 receptor alpha) on the surface of the cancer cell.
Persistent or recurrent cutaneous T-cell lymphoma expressing the CD25 component of IL-2 receptor
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Persistent or recurrent cutaneous T-cell lymphoma expressing the CD25 component of IL-2 receptor
Confirmed: the accelerated approval of 1999 converted to traditional approval 9.7 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 1999 | Persistent or recurrent CD25-positive CTCL (Ontak; withdrawn 2014) |
| US | 2024 | Relapsed or refractory stage I to III CTCL after at least one systemic therapy (Lymphir) |
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Query for this drug: (TITLE:"Denileukin diftitox" OR ABSTRACT:"Denileukin diftitox" OR TITLE:"Lymphir" OR ABSTRACT:"Lymphir" OR TITLE:"Ontak 1999 to 2014" OR ABSTRACT:"Ontak 1999 to 2014" OR TITLE:"E7777" OR ABSTRACT:"E7777") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Denileukin diftitox, not a curated reading list.