Citius Pharmaceuticals announced that the Company has submitted a Biologics License Application (BLA) to the FDA for I/ONTAK (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL)
Phase III trial of I/Ontak shows consistent results to previously marketed form in cutaneous T-cell lymphoma Citius Pharmaceuticals reported topline results from the pivotal Phase III trial of I/Ontak (E7777), an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL).
The FDA has accepted a biologics license application (BLA) seeking the approval of a reformulation of denileukin diftitox (I/Ontak; E7777) for use as a potential therapeutic option in patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL)