Drug Profile
Denileukin diftitox - Eisai
Alternative Names: DAB389IL-2; DAB389 interleukin-2; E7272; E7777; I/ONTAK; Interleukin-2 fusion toxin; LY 335348; LYMPHIRTM; ONTAK; RemitoroLatest Information Update: 25 Mar 2024
Price :
$50
*
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.
- 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)