Autolus — Aucatzyl EMA EPAR public assessment report (EMEA/H/C/005907, 2025)
Autolus · 2025 · EMA EPAR public assessment report
Report summary
The EMA granted conditional marketing authorization for Autolus's Aucatzyl (obecabtagene autoleucel; obe-cel), a CD19 CAR-T cell therapy, for relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL) in adults, addressing a significant unmet medical need. The approval is based on the pivotal FELIX study, demonstrating an overall response rate of 76.6%, median duration of response of 14.06 months, and median overall survival of 14.1 months. While effective, obe-cel carries safety concerns including cytokine release syndrome and neurotoxicity, with a split-dose regimen aiming to mitigate these. The report details the manufacturing process, non-clinical and clinical pharmacology, and post-authorization surveillance plans, including long-term studies to confirm efficacy and safety.
Key findings — cited to the page
| Incidence of Grade ≥3 CRS (Total) | 1.7 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Grade ≥3 ICANS for low disease burden regimen | 0 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Grade ≥3 CRS for high disease burden regimen | 2.8 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Any Grade CRS (Total) | 70.0 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Grade ≥3 ICANS for high disease burden regimen | 9.7 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Any Grade ICANS for low disease burden regimen | 10.4 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Grade ≥3 ICANS (Total) | 5.8 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Any Grade CRS for high disease burden regimen | 83.3 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Any Grade CRS for low disease burden regimen | 50.0 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Grade ≥3 CRS for low disease burden regimen | 0 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Any Grade ICANS for high disease burden regimen | 30.6 % | FELIX (Cohort Ib and II) · p.52 |
| Incidence of Any Grade ICANS (Total) | 22.5 % | FELIX (Cohort Ib and II) · p.52 |
Source: Autolus ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →