{"entity":{"id":"idecabtagene-vicleucel","kind":"drug","name":"Idecabtagene vicleucel","aka":[],"tldr":"Idecabtagene vicleucel was the first myeloma CAR-T (2021) and is now approved after two prior lines based on KarMMa-3.","summary":"Idecabtagene vicleucel is an autologous CAR-T in which a lentiviral vector adds a murine scFv anti-BCMA receptor with 4-1BB costimulation to the patient's T cells, infused once after lymphodepletion. It was the first myeloma CAR-T, approved in 2021 after at least 4 lines on KarMMa (ORR 73%, CR 33%). KarMMa-3 showed PFS 13.3 versus 4.4 months (HR 0.49) against standard regimens in triple-class-exposed patients, leading to approval after at least 2 lines in April 2024; OS was not significantly different unadjusted, and whether crossover-adjusted analyses favouring ide-cel should count remains debated. Cytokine release syndrome occurred in 88% (5% grade 3 or higher) and neurotoxicity in 15%; the REMS was removed in 2025. BMS and 2seventy bio developed it. It is a one-time infusion of engineered immune cells that tripled the time without progression in heavily pretreated myeloma.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Idecabtagene_vicleucel","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Idecabtagene%20vicleucel"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":["crs","icans","crossover"],"trials":["karmma-3","nct06045806"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Abecma","code":"ide-cel","modality":"CAR-T (BCMA)","mechanism":"Murine scFv anti-BCMA CAR with 4-1BB costimulation; lentiviral.","approvals":[{"region":"US","year":2021,"indication":"Relapsed/refractory myeloma after ≥4 lines"},{"region":"US","year":2024,"indication":"After ≥2 lines including IMiD, PI, and anti-CD38"}],"mechanismSteps":[],"dosing":{"route":"IV single infusion","schedule":"300-510 × 10⁶ CAR+ T cells after fludarabine/cyclophosphamide lymphodepletion","monitoring":"CRS, ICANS, prolonged cytopenias, infections; REMS removed 2025"},"toxicity":[{"event":"Cytokine release syndrome","anyGradePct":88,"grade3PlusPct":5,"note":"KarMMa-3"},{"event":"Neurotoxicity","anyGradePct":15,"grade3PlusPct":3},{"event":"Neutropenia","grade3PlusPct":76}],"access":[],"regulatoryEvents":[]},"route":"/drugs/idecabtagene-vicleucel/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"}],"technology":[{"id":"car-t-manufacturing-process","kind":"technology","name":"Autologous CAR-T manufacturing, batch by batch","route":"/technologies/car-t-manufacturing-process/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"bcma","kind":"target","name":"BCMA","route":"/targets/bcma/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"term":[{"id":"crossover","kind":"term","name":"Crossover in trials","route":"/terms/crossover/"},{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"icans","kind":"term","name":"ICANS (neurotoxicity)","route":"/terms/icans/"}],"trial":[{"id":"nct06045806","kind":"trial","name":"A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alo","route":"/trials/nct06045806/"},{"id":"karmma-3","kind":"trial","name":"KarMMa-3","route":"/trials/karmma-3/"}],"paper":[{"id":"paper-karmma-3-ide-cel-nejm-2023","kind":"paper","name":"KarMMa-3: ide-cel CAR-T versus standard regimens in triple-class-exposed relapsed myeloma","route":"/key-papers/paper-karmma-3-ide-cel-nejm-2023/"}],"biomarker":[{"id":"bcma-expression","kind":"biomarker","name":"BCMA expression","route":"/biomarkers/bcma-expression/"}]}}