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# FDA Accepts BLA Resubmission for Lymphir
- URL: https://www.fdaweb.com/fda-accepts-bla-resubmission-for-lymphir/
- Published: 2024-03-19T12:00:00.000Z
- Updated: 2026-09-14T14:25:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156590

FDA has accepted for review a Citius Pharmaceuticals BLA resubmission 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 FDA 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.