FDA nod for Citius’ Lymphir

Citius Pharmaceuticals has won US Food and Drug Administration (FDA) approval for Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of relapsed or refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Lymphir is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs. This is the first indication for the drug and the first FDA-approved product for Citius.

This approval marks the first novel targeted systemic therapy approved by the FDA for r/r CTCL since 2018. The submission was based on Phase III Pivotal Study 302 results, which demonstrated 36% objective response rate, reduction in skin disease in 84% of patients, clinically significant pruritis improvement, and no cumulative toxicity.