denileukin diftitox
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed primary cutaneous T-cell lymphoma 4 milestones | |||||
| Filed | US (FDA) | LYMPHIR | primary cutaneous T-cell lymphoma | 2024-02-14 | “today announced the resubmission of the Company's Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (denileukin diftitox)” citiuspharma.com ↗ “Resubmitted LYMPHIR™ (denileukin diftitox) biologics license application (BLA) to the U.S. Food and Drug Administration (FDA)” citiuspharma.com ↗ |
| Rejected (CRL) | US (FDA) | LYMPHIR | primary cutaneous T-cell lymphoma | 2023-07-29 | “today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the Company's Biologics License Application (BLA) seeking...” citiuspharma.com ↗ |
| Filed | US (FDA) | I/ONTAK | primary cutaneous T-cell lymphoma | 2022-09-28 | “today announced that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denileukin diftitox (I/ONTAK)” citiuspharma.com ↗ “Completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA)” citiuspharma.com ↗ |
| Filed | Japan (PMDA) | — | primary cutaneous T-cell lymphoma | 2020-03-26 | “submitted in Japan a marketing authorization application of the anticancer agent denileukin diftitox (genetic recombinant)” eisai.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | ONTAK | — | 2008-10-15 | fda.gov ↗ |
| Approved | US (FDA) | ONTAK | — | 1999-02-05 | fda.gov ↗ |
Trials 40
News releases announcing trial results or a regulatory action · 15
All press releases naming this drug 24 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | denileukin diftitox | “E7777 or denileukin diftitox is a recombinant cytotoxic fusion protein composed of the amino acid sequences for diphtheria toxin fragments A and B (Met1-Thr387)-His and for...” NCT05200559 ↗37“Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.” PMID 39700456 ↗ Dec 2024 “This study evaluated whether adding E7777 (a new formulation of denileukin diftitox [DD]) improved the efficacy of anti-PD-1 antibody therapy.” PMID 38022532 ↗ Oct 2023 “Denileukin diftitox is a recombinant fusion protein of human IL-2 and diptheria toxin fragment that also can kill CD25(+) T cells.” PMID 27330808 ↗ Jun 2016 “A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia” NCT00055146 ↗ “methotrexate, basiliximab, daclizumab, inolimomab, denileukin diftitox, alemtuzumab, ATG+ etanercept” NCT02694770 ↗ “Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients” NCT00051012 ↗ “an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox, ONTAK” NCT00224354 ↗ “Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients” NCT00050999 ↗ “Denileukin diftitox (ONTAK) induces a tolerogenic phenotype in dendritic cells” PMID 23958949 ↗ Aug 2013 “ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2)” NCT00337987 ↗ |
| Known as | DAB/IL2 | “a recombinant interleukin 2/diphtheria toxin conjugate (DAB/IL2; Denileukin Diftitox; Ontak)” PMID 18334033 ↗ Mar 2008 |
| Known as | DD-cxdl | “PURPOSE: Denileukin diftitox (DD)-cxdl is a fusion protein comprising diphtheria toxin fragments A and B and human interleukin-2.” PMID 39700456 ↗ Dec 2024 |
| Known as | denileukin | “Patients were randomized to receive methylprednisolone 2 mg/kg per day plus etanercept, mycophenolate mofetil (MMF), denileukin diftitox (denileukin), or pentostatin.” PMID 19443659 ↗ May 2009 |
| Known as | Denileukin Diftitox-Cxdl | “Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.” PMID 39700456 ↗ Dec 2024 |
| Known as | E7777 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01355783 ↗ |
| Known as | ONTAK | “A Multicenter Phase II Evaluation Of ONTAK (DENILEUKINDIFTITOX) In Patients With Low Or Intermediate Grade-B-Cell Non-Hodgkin's Lymphoma Who Have Been Treated Previously With A...” NCT00026429 ↗13“The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL)” NCT00211276 ↗ “Denileukin diftitox (ONTAK) is a diphtheria/IL-2R fusion protein able to deplete regulatory T cells in peripheral blood.” PMID 39362046 ↗ Oct 2024 “Denileukin diftitox (ONTAK) induces a tolerogenic phenotype in dendritic cells” PMID 23958949 ↗ Aug 2013 |
| Known as | ONTAK (denileukin diftitox) | “ONTAK (denileukin diftitox)” NCT00278369 ↗ |
| Action | Deplete | “Immunotoxins such as denileukin diftitox can locate cancer cells and kill them without harming normal cells.” NCT00003615 ↗ |
| Modality | Protein / enzyme biologic | “A Phase II Study of DAB 389 IL-2, an Interleukin-2 Fusion Toxin, for Previously Treated Stage II, III, and IV Follicular Low-Grade Non-Hodgkin's Lymphoma” NCT00003615 ↗ |
| Route | Intravenous | “Patients receive immunotoxin therapy with denileukin diftitox IV over 15-60 minutes on days 1-5.” NCT00003615 ↗ |