Denileukin Diftitox-cxdl Gains NCCN Category 2A Recommendation for Cutaneous T-cell Lymphoma Treatment

Citius Pharmaceuticals, Inc announced today that its newly FDA-approved therapy for cutaneous T-cell lymphoma (CTCL), denileukin diftitox-cxdl (Lymphir) has been added to the National Comprehensive Cancer Network's (NCCN) Clinical Practice Guidelines in Oncology.¹

The addition is based on category 2A recommendation from the NCCN, indicative of uniform consensus from the organization, establishing denileukin diftitox-cxdl as a valid and appropriate treatment option for patients with CTCL.

Image Credit: © DermNet; Te Whatu Ora Health New Zealand

In August, the US Food and Drug Administration approved denileukin diftitox-cxdl for treating adults with relapsed or refractory CTCL.² This new drug targets the IL-2 receptor found on both malignant and regulatory T-cells, marking it as the first of its kind for this condition.

The approval was based on a successful phase 3 clinical trial (NCT01871727),³ which involved administering the drug intravenously over 5 days in a 21-day cycle. The trial focused on determining the drug's safety, efficacy, and optimal dosage, as well as monitoring adverse effects and the presence of anti-IL-2 antibodies.

Results showed that denileukin diftitox-cxdl was effective for patients with recurrent or persistent CTCL and had a median response time of 1.4 months.

"NCCN guidelines are widely regarded as the gold standard for clinical decision-making in oncology and hematology, influencing treatment practices and payor reimbursement in the US," said Leonard Mazur, CEO of Citius and Citius Oncology, in a news release.¹

"We believe that Lymphir has the potential to improve CTCL patient outcomes, and expect its addition to the NCCN Guidelines may aid adoption and ease reimbursement, particularly for the anticipated patients that qualify for Center for Medicare and Medicaid coverage," Mazur said.

The drug is expected to provide a new option for managing CTCL, particularly for patients with symptomatic skin concerns. Dermatologists will prescribe the drug in coordination with a multidisciplinary team, including oncologists and other specialists.

"It’s very rewarding to see that we have an active agent that can help prolong patients’ survival, control their symptomatic diseases, and is just another important type of agent to use," said Myron Czuczman, MD, chief medical officer and EVP of Citius, in a previous interview with Dermatology Times.

References

1. Citius Pharmaceuticals, Inc. and Citius Oncology, Inc. announce LYMPHIR (denileukin diftitox-cxdl) added to national comprehensive cancer network (NCCN) Clinical Practice Guidelines in Oncology. News release. PR Newswire. September 5, 2024. Accessed September 5, 2024. https://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-and-citius-oncology-inc-announce-lymphir-denileukin-diftitox-cxdl-added-to-national-comprehensive-cancer-network-nccn-clinical-practice-guidelines-in-oncology-302239014.html
2. Citius Pharmaceuticals receives FDA approval for Lymphir (denileukin diftitox-cxdl) immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma. News release. PR Newswire. August 8, 2024. Accessed September 5, 2024. 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
3. A trial of E7777 in persistent and recurrent cutaneous T-cell lymphoma. Clinicaltrials.gov identifier: NCT01871727. Updated December 12, 2022. Accessed September 5, 2024. https://clinicaltrials.gov/study/NCT01871727