OnCo
drugsProductApproved2021🇪🇺🇬🇧🇯🇵🇦🇺

Idecabtagene vicleucel

Idecabtagene vicleucel was the first myeloma CAR-T (2021) and is now approved after two prior lines based on KarMMa-3.

KarMMa: ORR 73%, CR 33% in ≥3 prior lines. KarMMa-3: PFS 13.3 vs 4.4 months vs standard regimens (HR 0.49); OS not significantly different after crossover adjustment debate. Approved 2021 (≥4 lines) and April 2024 (≥2 lines, triple-class exposed). BMS/2seventy bio.

Schematic of the modality · CAR-T (BCMA) · not a molecule; see the CAR-T cell therapy page
How it works, step by step · animated schematic, not to scale
CAR-T cell therapy
Modality
CAR-T (BCMA)
Mechanism
Murine scFv anti-BCMA CAR with 4-1BB costimulation; lentiviral.
Brand / code
Abecma · ide-cel
Dosing & schedule
Route
IV single infusion
Schedule
300-510 × 10⁶ CAR+ T cells after fludarabine/cyclophosphamide lymphodepletion
Monitoring
CRS, ICANS, prolonged cytopenias, infections; REMS removed 2025
Medicare
Part B (clinician-administered)NCD 110.24

Autologous CAR-T covered nationally under NCD 110.24 for FDA-labelled indications at facilities enrolled in the FDA REMS. Inpatient administration is paid under Part A (MS-DRG 018); outpatient administration is a Part B drug. The product itself is bundled into the facility payment. HCPCS Q2055.

Commercial insurance
covered with prior authorisation

Covered with prior authorisation and usually a single-case agreement with a certified treatment centre; many plans restrict to centres of excellence and require documentation of prior lines of therapy.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · CMS NCD 110.24: Chimeric antigen receptor (CAR) T-cell therapy · Medicare.gov: Inpatient hospital care (Part A). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
Licensed 2021 for myeloma after 3 or more treatments; NICE appraisals 2023-25 (including KarMMa-3 earlier-line use). Check NICE.

Sources: NICE search: idecabtagene vicleucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2021Relapsed/refractory myeloma after ≥4 lines
US2024After ≥2 lines including IMiD, PI, and anti-CD38

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Cytokine release syndrome
88%
5%
Neurotoxicity
15%
3%
Neutropenia
76%

KarMMa-3. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
13 studies3 recruiting11 Phase 22 Phase 3
Search “Idecabtagene vicleucel” 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
Idecabtagene vicleucel
intervention: Idecabtagene vicleucel
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Literature trend79 papers in the last 12 months+25% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Idecabtagene vicleucel" OR ABSTRACT:"Idecabtagene vicleucel" OR TITLE:"Abecma" OR ABSTRACT:"Abecma" OR TITLE:"ide-cel" OR ABSTRACT:"ide-cel") 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 Idecabtagene vicleucel, not a curated reading list.

Connected

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