FDA Approval Insights: Denileukin Diftitox in Relapsed/Refractory CTCL

In today’s episode, supported by Citius Pharmaceuticals, we had the pleasure of speaking with Francine Foss, MD, to discuss the FDA approval of denileukin diftitox-cxdl (Lymphir) for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL) who have received 1 or more prior systemic therapies. Dr Foss is a professor of medicine (hematology) and dermatology and the director of the Multidisciplinary T Cell Lymphoma Program at the Yale School of Medicine, as well as the scientific leader of Lymphoma CRT at Yale Cancer Center in New Haven, Connecticut. 

On August 8, 2024, the FDA approved denileukin diftitox for the treatment of patients with relapsed/refractory CTCL who have received at least 1 prior systemic therapy. This regulatory decision was supported by findings from the phase 3 Study 302 (NCT01871727), in which patients who received the agent (n = 69) achieved an objective response rate of 36.2% (95% CI, 25.0%-48.7%) per independent review committee assessment, including a complete response rate of 8.7%.

In our exclusive interview, Dr Foss discussed the significance of this approval, key efficacy and safety data from Study 302, and her excitement about reintroducing an agent to the CTCL treatment paradigm that can induce particularly robust responses.