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Denileukin diftitox
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Denileukin diftitox
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.
Denileukin diftitox-cxdl, sold under the brand name LYMPHIR, is an interleukin-2 (IL-2) receptor–directed cytotoxin (immunotoxin) used to treat cutaneous T-cell lymphoma (CTCL). It is a recombinant fusion protein that combines an IL-2 ligand with a fragment of diphtheria toxin.
In 2024, the U.S. Food and Drug Administration (FDA) approved denileukin diftitox-cxdl in the United States. for the treatment of adults with relapsed or refractory stage I–III CTCL after at least one prior systemic therapy. Denileukin diftitox-cxdl is administered by intravenous infusion.
A prior formulation of denileukin diftitox (marketed as Ontak) was approved in 1999 and was voluntarily withdrawn from the U.S. market in 2014. In 2021, the current more bioactive formulation was also approved in Japan.
In the United States, denileukin diftitox-cxdl is indicated for the treatment of adults with relapsed or refractory stage I–III CTCL after at least one prior systemic therapy.
CTCL is a rare, chronic, and essentially incurable form of cutaneous non-Hodgkin lymphoma. Mycosis fungoides (MF) and Sézary syndrome (SS) account for the majority of CTCL cases. The disease causes cancerous T cells to initially infiltrate the skin, producing debilitating lesions, plaques, severe pruritus (itching), and/or erythroderma; CTCL may also spread to lymph nodes, blood, or visceral organs Because it is incurable and treatment options are limited, patients typically cycle through multiple lines of therapy.
The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Primary Cutaneous Lymphomas list denileukin diftitox-cxdl as a systemic treatment option for relapsed or refractory mycosis fungoides and Sézary syndrome.
Denileukin diftitox-cxdl is a recombinant cytotoxic fusion protein consisting of an interleukin-2 (IL-2) (Ala1-Thr133) targeting domain fused to diphtheria toxin fragments A and B (Met1-Thr387)-His.
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Denileukin diftitox
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.
Denileukin diftitox-cxdl, sold under the brand name LYMPHIR, is an interleukin-2 (IL-2) receptor–directed cytotoxin (immunotoxin) used to treat cutaneous T-cell lymphoma (CTCL). It is a recombinant fusion protein that combines an IL-2 ligand with a fragment of diphtheria toxin.
In 2024, the U.S. Food and Drug Administration (FDA) approved denileukin diftitox-cxdl in the United States. for the treatment of adults with relapsed or refractory stage I–III CTCL after at least one prior systemic therapy. Denileukin diftitox-cxdl is administered by intravenous infusion.
A prior formulation of denileukin diftitox (marketed as Ontak) was approved in 1999 and was voluntarily withdrawn from the U.S. market in 2014. In 2021, the current more bioactive formulation was also approved in Japan.
In the United States, denileukin diftitox-cxdl is indicated for the treatment of adults with relapsed or refractory stage I–III CTCL after at least one prior systemic therapy.
CTCL is a rare, chronic, and essentially incurable form of cutaneous non-Hodgkin lymphoma. Mycosis fungoides (MF) and Sézary syndrome (SS) account for the majority of CTCL cases. The disease causes cancerous T cells to initially infiltrate the skin, producing debilitating lesions, plaques, severe pruritus (itching), and/or erythroderma; CTCL may also spread to lymph nodes, blood, or visceral organs Because it is incurable and treatment options are limited, patients typically cycle through multiple lines of therapy.
The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Primary Cutaneous Lymphomas list denileukin diftitox-cxdl as a systemic treatment option for relapsed or refractory mycosis fungoides and Sézary syndrome.
Denileukin diftitox-cxdl is a recombinant cytotoxic fusion protein consisting of an interleukin-2 (IL-2) (Ala1-Thr133) targeting domain fused to diphtheria toxin fragments A and B (Met1-Thr387)-His.