Citius Pharmaceuticals’ application for denileukin diftitox approved by FDA

Citius Pharmaceuticals’ Biologics License Application for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma, has been accepted by the FDA . I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK. The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study.