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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.

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Interleukin-2 (aldesleukin is recombinant IL-2) (PDB 1M47), backbone trace
RCSB PDB
Modality
Recombinant interleukin-2 (cytokine)
Mechanism
Activates IL-2 receptors on T and NK cells, driving proliferation and cytotoxicity; high doses cause capillary leak.
Brand / code
Proleukin
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.

Not appraisedSearch NICE
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Licensed for metastatic RCC since 1989; largely superseded and rarely used on the NHS.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.

Regulatory

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Approvals

RegionYearIndication
US1992Metastatic renal cell carcinoma
US1998Metastatic melanoma

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
350 studies5 recruiting90 Phase 212 Phase 3
Search “Aldesleukin” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Aldesleukin (high-dose IL-2)
intervention: Aldesleukin
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query 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.

Connected

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