{"entity":{"id":"aldesleukin","kind":"drug","name":"Aldesleukin (high-dose IL-2)","aka":["Interleukin-2","IL-2","Recombinant interleukin-2"],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Aldesleukin","links":[{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=aldesleukin"}],"tags":["gap-fill","historic"],"related":[],"cancers":["rcc","melanoma"],"sections":[],"technologies":["cytokine-therapy","til-therapy"],"targets":[],"drugs":[],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06119685","nct07681596"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Proleukin","modality":"Recombinant interleukin-2 (cytokine)","mechanism":"Activates IL-2 receptors on T and NK cells, driving proliferation and cytotoxicity; high doses cause capillary leak.","approvals":[{"region":"US","year":1992,"indication":"Metastatic renal cell carcinoma"},{"region":"US","year":1998,"indication":"Metastatic melanoma"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/aldesleukin/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"neuroblastoma-high-risk","kind":"cancer","name":"High-risk neuroblastoma","route":"/cancers/neuroblastoma-high-risk/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"}],"technology":[{"id":"cytokine-therapy","kind":"technology","name":"Cytokines & engineered cytokines","route":"/technologies/cytokine-therapy/"},{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}],"company":[{"id":"iovance","kind":"company","name":"Iovance Biotherapeutics","route":"/companies/iovance/"}],"trial":[{"id":"nct07681596","kind":"trial","name":"A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma","route":"/trials/nct07681596/"},{"id":"nct02830724","kind":"trial","name":"Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers","route":"/trials/nct02830724/"},{"id":"nct03190941","kind":"trial","name":"Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients","route":"/trials/nct03190941/"},{"id":"nct05296564","kind":"trial","name":"Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers","route":"/trials/nct05296564/"},{"id":"nct06530303","kind":"trial","name":"Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer","route":"/trials/nct06530303/"},{"id":"nct05810792","kind":"trial","name":"Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer","route":"/trials/nct05810792/"},{"id":"nct06119685","kind":"trial","name":"IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers","route":"/trials/nct06119685/"},{"id":"nct01174121","kind":"trial","name":"Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer","route":"/trials/nct01174121/"},{"id":"study-0201","kind":"trial","name":"Study 0201","route":"/trials/study-0201/"},{"id":"nct05267626","kind":"trial","name":"Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Ca","route":"/trials/nct05267626/"},{"id":"nct01700946","kind":"trial","name":"Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma","route":"/trials/nct01700946/"},{"id":"nct06532812","kind":"trial","name":"TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer","route":"/trials/nct06532812/"}],"person":[{"id":"sharon-belvin","kind":"person","name":"Sharon Belvin","route":"/people/sharon-belvin/"}],"paper":[{"id":"paper-c-144-01-lifileucel-melanoma-jco-2021","kind":"paper","name":"C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed","route":"/key-papers/paper-c-144-01-lifileucel-melanoma-jco-2021/"},{"id":"paper-study-0201-blood-2006","kind":"paper","name":"Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial","route":"/key-papers/paper-study-0201-blood-2006/"},{"id":"paper-rohaas-til-vs-ipilimumab-nejm-2022","kind":"paper","name":"Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma","route":"/key-papers/paper-rohaas-til-vs-ipilimumab-nejm-2022/"}],"term":[{"id":"cytokine","kind":"term","name":"Cytokine","route":"/terms/cytokine/"}],"institution":[{"id":"nci-ccr","kind":"institution","name":"NCI Center for Cancer Research (intramural programme)","route":"/institutions/nci-ccr/"}],"drug":[{"id":"histamine-dihydrochloride","kind":"drug","name":"Histamine dihydrochloride","route":"/drugs/histamine-dihydrochloride/"}]}}