When will LYMPHIR be available?
On August 7, 2024, the FDA issued a biologics license to market LYMPHIR for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy. The basis of the approval is clinical safety and efficacy data from trial E7777-G000-302. Citius Pharmaceuticals is working to make LYMPHIR available as soon as possible and have provided an email sign up so that you can be informed of its availability.
Citius Pharmaceuticals Receives FDA Approval for LYMPHIR™ (denileukin diftitox-cxdl) Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma
August 2024 - Citius Pharmaceuticals has issued a press release that their novel immunotherapy for treating cutaneous lymphoma, LYMPHIR, has received U.S. Food and Drug Administration (FDA) approval. LYMPHIR is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs.
The approval of LYMPHIR is based on results from the Phase 3 Pivotal Study 302 (NCT01871727) of CTCL patients who had previously received at least one systemic treatment.
To read the full press release, visit: https://citiuspharma.com/investors/news-media/news/release-details/2024/Citius-Pharmaceuticals-Receives-FDA-Approval-for-LYMPHIR-denileukin-diftitox-cxdl-Immunotherapy-for-the-Treatment-of-Adults-with-Relapsed-or-Refractory-Cutaneous-T-Cell-Lymphoma/default.aspx
Denileukin diftitox (Dd) was approved and marketed as ONTAK in the US from 1999-2014 for treatment of patients with relapsed/refractory CTCL. ONTAK was voluntarily taken off the market in 2014 due to manufacturing difficulties. E7777 (improved purity Denileukin diftitox [ONTAK]) was developed as a result of a refined manufacturing process. E7777 has ~1.5-2 times greater specific bioactivity in non-clinical assays compared with ONTAK and is considered a new drug by the FDA.
Source:
H. Miles Miles Prince, Larisa J Geskin, Oleg E Akilov, Timothy M. Kuzel, Christiane Querfeld, Chean Eng Ooi, Dongyuan Xing, Nicholas Sauter, Preeti Singh, Myron Czuczman, Francine M. Foss; Safety and Tolerability of E7777 (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma: Results from Pivotal Study 302. Blood 2022; 140 (Supplement 1): 6577–6578. doi: https://doi.org/10.1182/blood-2022-167564