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Denileukin diftitox - Eisai

Drug Profile

Denileukin diftitox - Eisai

Alternative Names: DAB389IL-2; DAB389 interleukin-2; E7272; E7777; I/ONTAK; Interleukin-2 fusion toxin; LY 335348; LYMPHIRTM; ONTAK; Remitoro

Latest Information Update: 18 Apr 2024

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At a glance

  • Originator Ajinomoto; Japanese Foundation for Cancer Research
  • Developer Citius Pharmaceuticals Inc; Eisai Co Ltd
  • Class ADP ribose transferases; Anti-inflammatories; Antineoplastics; Antipsoriatics; Antiretrovirals; Antirheumatics; Bacterial toxins; Interleukins; Recombinant fusion proteins; Skin disorder therapies
  • Mechanism of Action Protein synthesis inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Cutaneous T-cell lymphoma; Peripheral T-cell lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cutaneous T-cell lymphoma; Peripheral T-cell lymphoma
  • Phase II Malignant melanoma
  • Phase I/II Diffuse large B cell lymphoma
  • Discontinued Alopecia; Atopic dermatitis; HIV infections; Inflammatory bowel diseases; Multiple sclerosis; Psoriasis; Rheumatoid arthritis; Transplant rejection

Most Recent Events

  • 18 Mar 2024 FDA assigns PDUFA action date of 13/08/2024 for Denileukin Diftitox for Cutaneous T-cell lymphoma (Second-line therapy, Recurrent)
  • 18 Mar 2024 US FDA accepts BLA for Denileukin Diftitox for refractory or relapsed Cutaneous T-cell lymphoma for review
  • 14 Feb 2024 Preregistration for Cutaneous T-cell lymphoma (Second-line therapy or greater) in USA (IV)
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