FDA Accepts BLA for Denileukin Diftitox for Those With Cutaneous T-Cell Lymphoma
E7777 is an engineered interleukin-2-diphtheria toxin fusion protein that is a purified and more bioactive formulation of Ontak, which the agency previously approved.
The FDA has accepted a biologics license application for denileukin diftitox (I/Ontak, E7777; Citius Pharmaceuticals Inc) for the treatment of individuals with persistent or recurrent cutaneous T-cell lymphoma (CTCL).1
E7777 is an engineered interleukin-2-diphtheria toxin fusion protein. It is a purified and more bioactive formulation of Ontak, which the FDA previously approved.1
“The acceptance of the previously announced biologics license application submission for [E7777] is another important regulatory milestone for our oncology program,” Leonard Mazur, chairman and CEO of Citius, said in a statement. “We look forward to the potential approval of this therapeutic for patients with persistent or recurrent cutaneous T-cell lymphoma, a rare disease for which patients with advanced disease have limited treatment options.”1
The Prescription Drug User Fee Act target action date is September 28, 2023. The biologics license application is based on results from a pivotal phase 3 study (NCT01871727).1
The multicenter study of E7777 was an open-label trial for individuals with persistent or recurrent CTCL, consisting of a lead-in portion to select the recommended dose of the drug during the main parts of the study. The main part of the study was used to evaluate the efficacy of E7777.2
The trial consisted of 3 phases: pretreatment, treatment, and an extension and follow-up period.2
There were 112 individuals included in the study, with a start date was May 30, 2013, a primary completion date of December 6, 2021, and a study completion date of December 14, 2021.2
Investigators administered E7777 9 mcg/kg intravenously over 60 minutes on 5 consecutive days during every cycle of 21 days.2
The primary outcomes of the study were dose-limiting toxicities in the lead-in part of the study during the first 21 days, maximum tolerated dose in the lead-in part of the study for up to 12 months, and overall response rate in the main study from day 1 until disease progression or recurrence, or up to 30 months.2
References
1. Citius Pharmaceuticals Inc announces US Food and Drug Administration acceptance of biologics license application of denileukin diftitox for the treatment of patients with persistent or recurrent cutaneous t-cell lymphoma. Yahoo! Finance. News release. December 1, 2022. Accessed December 2, 2022. https://finance.yahoo.com/news/citius-pharmaceuticals-inc-announces-u-123000919.html
2. A trial of E7777 in persistent and recurrent cutaneous T-cell lymphoma. ClinicalTrials.gov. Updated December 5, 2022. Accessed December 12, 2022. https://beta.clinicaltrials.gov/study/NCT05074472
