Lymphir FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 12, 2024.
FDA Approved: Yes (First approved August 7, 2024)
Brand name: Lymphir
Generic name: denileukin diftitox-cxdl
Dosage form: for Injection
Company: Citius Pharmaceuticals, Inc.
Treatment for: Cutaneous T-cell Lymphoma
Lymphir (denileukin diftitox-cxdl) is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy.
- 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 contains denileukin diftitox-cxdl, a recombinant engineered fusion protein that combines interleukin-2 and diphtheria toxin. The agent specifically binds to IL2 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.
- 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 Ontak was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market.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.
- FDA approval of Lymphir was based on results from the Phase 3 Pivotal Study 302 that demonstrated an Objective Response Rate (ORR) of 36% and a Complete Response (CR) of 8.7%. The median time to response was 1.41 months and the duration of response was at least 6 months for 52% of patients. 84% of patients had a decrease in skin tumor burden and 12.5% saw complete clearing of skin disease.
- Lymphir is administered as an intravenous infusion on Days 1 through 5 of a 21-day cycle. Premedications of an antipyretic (acetaminophen), an antihistamine, and an antiemetic are administered prior to starting Lymphir in cycles 1 through 3 to reduce the risk of infusion-related reactions.
- The product label for Lymphir carries a Boxed Warning for Capillary leak syndrome (CLS). Warnings and precautions associated with Lymphir include visual impairment, infusion-related reactions, hepatotoxicity, and fetal harm. As part of the approval for Lymphir, the FDA has advised that a further clinical trial is required to characterize the known serious risk of visual impairment.
- Common adverse reactions include nausea, edema, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome. Common laboratory abnormalities include increased transaminases, decreased albumin, and decreased hemoglobin.
Development timeline for Lymphir
Further information
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