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# FDA OKs Cutaneous T-cell Lymphoma Therapy
- URL: https://www.fdaweb.com/fda-oks-cutaneous-t-cell-lymphoma-therapy/
- Published: 2024-08-08T12:00:00.000Z
- Updated: 2026-09-14T14:37:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157534

FDA has approved a Citius Pharmaceuticals BLA for Lymphir (denileukin diftitox-cxdl) for treating relapsed or refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The therapy is designed to target the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs, according to the company.

Approval is based on data from the Phase 3 Pivotal Study 302 ([NCT01871727](https://c212.net/c/link/?t=0&l=en&o=4228927-1&h=2833891425&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT01871727&a=NCT01871727&ref=fdaweb.com)) of CTCL patients who had previously received at least one systemic treatment. The primary efficacy outcome measure was objective response rate, which was 36.2%, with 8.7% achieving a complete response, according to the company. “Duration of response was at least six months for 52.0% of the patients,” it says.

CTCL is described as a rare and debilitating chronic non-Hodgkin lymphoma that primarily affects the skin. Around 3,000 patients are diagnosed each year with an estimated 40,000 living with the disease, according to Citius, adding that patients have limited treatment options.