Lymphir FDA Approval Status
FDA Approved: No
Brand name: Lymphir
Generic name: denileukin diftitox-cxdl
Company: Citius Pharmaceuticals, Inc.
Treatment for: Cutaneous T-cell Lymphoma
Lymphir (denileukin diftitox-cxdl) is an IL-2-based immunotherapy in development for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma.
- Cutaneous T-cell lymphoma (CTCL) is a type of non-Hodgkin lymphoma. It is caused when the T-cells, (a type of white blood cell) become cancerous and develop into skin lesions.
- Lymphir is a purified reformulation of denileukin diftitox, a cancer immunotherapy first approved in 1999 under the brand name Ontak for the treatment of persistent or recurrent CTCL. Ontak was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Lymphir is thought to feature greater purity and bioactivity compared to the original formulation.
- Lymphir is a recombinant engineered fusion protein that combines interleukin-2 and diphtheria toxin. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. Its unique mechanism of action targets both malignant T-cells and immunosuppressive regulatory T-cells (Tregs). Transiently eliminating Tregs has the potential of unleashing potent immune responses by the patient's immune system against their tumors.
- A Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) for Lymphir for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
Development timeline for Lymphir
Further information
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