Citius Pharma Refiles BLA for Lymphoma

Citius Pharmaceuticals has resubmitted a BLA for Lymphir (denileukin diftitox), an interleukin-2-based immunotherapy for treating patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy.

The resubmission addresses issues raised in a 7/28/2023 complete response letter. “Citius believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter,” a company release says. “There were no safety or efficacy issues cited and no additional trials were required.”

Lymphir is described as a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. “The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis,” Citius says.