On Monday, Citius Oncology announced the U.S. launch of Lymphir (denileukin diftitox-cxdl), the first FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) since 2018.
LYMPHIR (denileukin diftitox-cxdl). Credit: Citius Oncology
Lymphir is an IL-2 receptor-directed fusion protein that kills cancer cells by binding to the IL-2 receptors found on the regulatory T-cells and releasing a toxin that inhibits protein synthesis, leading to cell death. The treatment is approved for adult patients with relapsed or refractory (r/r) stage 1 to 3 CTCL after at least one prior therapy.
“With a median time to response of 1.4 months in the Phase 3 trial, we believe LYMPHIR may offer rapid skin relief, among other benefits, to patients suffering from severe and debilitating itching common with the disease,” said Leonard Mazur, chairman and CEO of Citius Oncology and Citius Pharmaceuticals.
The Phase 3 clinical trial demonstrated an objective response rate (ORR; a measure of partial response or complete response in a given time frame) of 36.2%. Additionally, 84% of patients experienced a reduction in skin tumor burden.
CTCL is a rare blood cancer with 3,000 new cases reported annually in the U.S. The only curative therapy before Lymphir was allogeneic stem cell transplantation, which is only an option for a small subset of the patient population. Other patients cycle through treatments as the disease becomes resistant.
Citius also stated that Lymphir may have potential as a therapy for peripheral T-cell lymphoma (PTCL).
The growing CTCL market
“Ultimately, we expect LYMPHIR to be a meaningful addition to the treatment paradigm for CTCL and a value-driving catalyst for Citius Oncology shareholders. We estimate that LYMPHIR is entering a growing U.S. market valued at over $400 million, with further upside opportunities through international market access and potential expanded indications in the future,” said Mazur.
Delveinsight estimated the CTCL market size at $1.04 billion in 2025, projecting it to expand at a CAGR of 5%, reaching $1.62 billion by 2034.
Citius Oncology stock was up 19.71% Monday afternoon, even as parent company Citius Pharmaceuticals fell 6.25%. Citius Oncology is up 37.82% YTD.
Citius reported that the oncology subsidiary raised $9 million in gross financings for the Lymphir launch in July.
Citius Pharma’s late-stage pipeline also includes Mino-Lok, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids.
Filed Under: Oncology
