LYMPHIR
LYMPHIR is a CD25-directed cytotoxin indicated for the treatment of adult patients with cutaneous T-cell lymphoma (CTCL). It is specifically approved for patients with relapsed or refractory Stage I-III disease who have previously received at least one systemic therapy. This therapeutic agent provides a targeted treatment option for individuals whose cancer has not responded to or has returned after initial systemic interventions.
How LYMPHIR Works
LYMPHIR is a fusion protein designed to direct the cytocidal action of diphtheria toxin to cells expressing the IL-2 receptor. Once the drug is taken up by the cell, the toxin fragment is cleaved and inhibits protein synthesis, resulting in cell death. This mechanism allows the drug to deplete immunosuppressive regulatory T lymphocytes and exert direct antitumor activity on IL-2 receptor-expressing tumors.
Details
- Status
- Prescription
- First Approved
- 2024-08-07
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LYMPHIR Approval History
What LYMPHIR Treats
1 indicationsLYMPHIR is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cutaneous T-Cell Lymphoma
LYMPHIR Boxed Warning
CAPILLARY LEAK SYNDROME Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity [see Dosage and Administration ( 2.1 , 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary leak syndrome (CLS), ...
WARNING: CAPILLARY LEAK SYNDROME Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity [see Dosage and Administration ( 2.1 , 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LYMPHIR FDA Label Details
ProIndications & Usage
FDA Label (PDF)LYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
WARNING: CAPILLARY LEAK SYNDROME Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity [...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.