Aldesleukin (high-dose IL-2)
High-dose interleukin-2 was the first immunotherapy to cure a small fraction of patients with metastatic melanoma and kidney cancer, at the cost of ICU-level toxicity; today it mainly supports TIL therapy.
Approved 1992 (RCC) and 1998 (melanoma) on ~15% response with ~5-7% durable complete responses (Rosenberg). Capillary leak, hypotension and multi-organ effects confine it to specialised centres. Now used as a short course after lifileucel (TIL) infusion; engineered IL-2 variants (bempegaldesleukin) failed in phase 3.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. High-dose IL-2 is given as an inpatient course, so hospital stays fall under Part A.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- Licensed for metastatic RCC since 1989; largely superseded and rarely used on the NHS. No TA.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: aldesleukin (high-dose IL-2). Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 1992 | Metastatic renal cell carcinoma |
| US | 1998 | Metastatic melanoma |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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This trial supplied the randomised proof that was missing for TIL therapy and showed academic centres can run cell-therapy phase 3 trials without industry. It supports TIL as a standard option after checkpoint inhibitor failure in melanoma and underpinned reimbursement in the Netherlands. The comparator, ipilimumab, is itself only modestly effective in this setting, and overall survival did not differ significantly.
Lifileucel proved that Steven Rosenberg's decades-old TIL concept could be industrialised into a licensed product and gave patients with checkpoint-refractory melanoma, who otherwise have few options, a chance of durable remission. It is the first cell therapy approved for any solid tumour. The treatment requires surgery to harvest tumour, hospitalisation for lymphodepletion and IL-2, and specialised centres, so its reach is limited.
Latest papers
topQuery for this drug: (TITLE:"Aldesleukin" OR ABSTRACT:"Aldesleukin" OR TITLE:"high-dose IL-2" OR ABSTRACT:"high-dose IL-2" OR TITLE:"Proleukin" OR ABSTRACT:"Proleukin") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Aldesleukin (high-dose IL-2), not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductInterferon alfa-2a/2b
Shares Cytokines & engineered cytokines, Renal cell carcinoma, Melanoma and the tags gap-fill, historic.
- ProductThalidomide
Shares the tags gap-fill, historic.
- ProductMifamurtide
Shares Cytokines & engineered cytokines and the tag gap-fill.
- PersonSteven A. Rosenberg
Shares C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, NCI Center for Cancer Research (intramural programme), Cytokines & engineered cytokines, TIL therapy.
- ProductRopeginterferon alfa-2b
Shares Cytokines & engineered cytokines and the tag gap-fill.
- ProductTemsirolimus
Shares Renal cell carcinoma and the tag gap-fill.
- CollectionMelanoma Research Alliance (MRA)
Shares TIL therapy, Melanoma and the tag gap-fill.
- TermCancer during pregnancy
Shares Melanoma and the tag gap-fill.