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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.
Autologous T cells with a CD19 CAR using the CAT scFv (fast target dissociation), 4-1BB costimulation; split-dose infusion by marrow blast burden. Connects to CD19.
1.Leukapheresis and lentiviral transduction with the CAT-CD19 CAR
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
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.
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.
Sources: NICE TA1116. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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FELIX; approved without REMS source
| 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.
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Query 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.
Shares ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, Relapsed and refractory acute lymphoblastic leukaemia in children, Cytokine release syndrome (CRS), CD19.
Shares Autologous CAR-T manufacturing, batch by batch, ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19.
Shares ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, CD19, CAR-T cell therapy, Acute lymphoblastic leukaemia.
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, CAR-T cell therapy.
Shares Relapsed and refractory acute lymphoblastic leukaemia in children, Childhood cancers (all types), Acute lymphoblastic leukaemia.
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, CAR-T cell therapy.
Shares Autologous CAR-T manufacturing, batch by batch, ICANS (neurotoxicity), Cytokine release syndrome (CRS), CAR-T cell therapy.
Shares CD19, CAR-T cell therapy, Acute lymphoblastic leukaemia.