February 2025 - In a recent press release Citius Pharmaceuticals announced the following information about LYMPHIR™:
LYMPHIR™ (denileukin diftitox-cxdl) has been assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) by the Centers for Medicare & Medicaid Services (CMS).
Effective April 1, 2025, healthcare providers may use the permanent J-code, J9161 (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram), when submitting claims for LYMPHIR.
"The establishment of a permanent J-code marks a critical milestone in supporting patient access to LYMPHIR, providing coding clarity for physicians and facilities who administer LYMPHIR, and facilitating reimbursement. This achievement is a key step in ensuring that LYMPHIR is accessible to patients with commercial and government insurance (VA, DoD, Medicare) coverage," stated Leonard Mazur, Chairman and CEO of Citius Pharma and Citius Oncology.
J-codes are unique identifiers utilized by U.S. government and commercial payers, as well as physicians and their office staff, to streamline the billing and reimbursement process for infused therapies and certain other treatments.
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