Obecabtagene autoleucel
A CD19 CAR-T built to grip and release quickly, which cut severe side effects and gave adults with relapsed ALL a real chance at durable remission.
FELIX (n=127 infused): ORR 77%, CR 55%, median EFS 11.9 months, with grade ≥3 CRS 2.4% and grade ≥3 ICANS 7%, far lower than first-generation CD19 CARs; longer follow-up shows ~40% event-free at 2 years, most without transplant. Approved 8 November 2024 (US) for adults with relapsed/refractory B-ALL, without a REMS. The low-affinity, fast-off-rate binder (CAT) reduces exhaustion and cytokine release.
1.Leukapheresis and lentiviral transduction with the CAT-CD19 CAR
- Route
- IV, split infusion
- Schedule
- Total 410 × 10^6 CAR+ cells given on day 1 and day 10; day-1 fraction depends on marrow blasts (≤20% vs >20%)
- Monitoring
- CRS/ICANS (boxed warning) but no REMS; cytopenias; infections
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- 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. FDA-approved November 2024 for adult relapsed/refractory B-ALL.
- 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.
- Assistance programmes
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
- UK-developed (UCL/Autolus) CD19 CAR-T; MHRA-licensed 2025 for adult relapsed or refractory B-ALL; NICE appraisal 2025-26.
Sources: NICE search: obecabtagene autoleucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
- 8 Nov 2024ApprovalUS
FELIX; approved without REMS source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Relapsed or refractory B-cell precursor ALL, adults |
| EU | 2025 | Relapsed or refractory B-ALL, adults ≥26 years |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Cytokine release syndrome | 69% | 2.4% |
| ICANS | 23% | 7% |
| Prolonged cytopenias | — | — |
Common; infection prophylaxis. Rates read from the source. 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:"Obecabtagene autoleucel" OR ABSTRACT:"Obecabtagene autoleucel" OR TITLE:"Aucatzyl" OR ABSTRACT:"Aucatzyl" OR TITLE:"obe-cel" OR ABSTRACT:"obe-cel" OR TITLE:"AUTO1" OR ABSTRACT:"AUTO1") 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 Obecabtagene autoleucel, not a curated reading list.
Pages like this
not linked directly; found by shared links- TrialELIANA
Shares ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, Cytokine release syndrome (CRS), CD19, Acute lymphoblastic leukaemia.
- ProductBrexucabtagene autoleucel
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19, Acute lymphoblastic leukaemia.
- ProductTisagenlecleucel
Shares ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19.
- Key paperUCART19: the first gene-edited, donor-derived CAR-T cells in children and adults with relapsed B-cell ALL
Shares ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, Cytokine release syndrome (CRS), CD19, Acute lymphoblastic leukaemia.
- PersonJae H. Park
Shares CD19, Acute lymphoblastic leukaemia, CAR-T cell therapy.
- Key paperMaude 2014: CD19 CAR-T cells produce complete remission in 27 of 30 children and adults with relapsed ALL
Shares ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, Cytokine release syndrome (CRS), CD19, Acute lymphoblastic leukaemia.
- PersonCarl H. June
Shares ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, CD19, Acute lymphoblastic leukaemia, CAR-T cell therapy.
- Key paperJULIET: tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19, CAR-T cell therapy.