Citius FDA OKd for Cutaneous T-Cell Lymphoma Therapy

 

• Only systemic treatment for relapsed or refractory (r/r) CTCL to target the IL-2 receptor on malignant T-cells and Tregs
• LYMPHIR is expected to launch within the next five months
• LYMPHIR's approval marks the first novel targeted systemic therapy approved by the FDA r/r CTCL since 2018
• Approval based on Phase 3 Pivotal Study 302 results that demonstrated 36% ORR, reduction in skin disease in 84% of patients, clinically significant pruritis improvement, and no cumulative toxicity

https://www.prnewswire.com/news-releases/citius-pharmaceuticals-receives-fda-approval-for-lymphir-denileukin-diftitox-cxdl-immunotherapy-for-the-treatment-of-adults-with-relapsed-or-refractory-cutaneous-t-cell-lymphoma-302217630.html