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.
- 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.
- 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.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Relapsed/refractory myeloma after ≥4 lines |
| US | 2024 | After ≥2 lines including IMiD, PI, and anti-CD38 |
| Adverse event | Any grade | Grade 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
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- InstitutionComprehensive Cancer Center Mainfranken, University Hospital Würzburg
Shares ICANS (neurotoxicity), BCMA, Cytokine release syndrome (CRS), Multiple myeloma.
- Key paperCARTITUDE-1: cilta-cel, a BCMA CAR-T, in heavily pretreated myeloma
Shares ICANS (neurotoxicity), BCMA, Cytokine release syndrome (CRS), Multiple myeloma.
- ProductLisocabtagene maraleucel
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), Bristol Myers Squibb, CAR-T cell therapy.
- ProductBrexucabtagene autoleucel
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), CAR-T cell therapy.
- ProductAnitocabtagene autoleucel
Shares BCMA, Multiple myeloma, CAR-T cell therapy.
- Key paperCARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy
Shares KarMMa-3: ide-cel CAR-T versus standard regimens in triple-class-exposed relapsed myeloma, BCMA, Cytokine release syndrome (CRS), Multiple myeloma.
- IdeaHospital-made CAR-T under one shared regulatory master file
Shares BCMA, Multiple myeloma, CAR-T cell therapy.
- ProductObecabtagene autoleucel
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), CAR-T cell therapy.