First CAR T Therapy for Relapsed or Refractory Adult ALL Now Reimbursed in Ireland
1st December 2025, DUBLIN, IRELAND -– Gilead Sciences Ltd. and Kite, a Gilead company, today announced that eligible patients in Ireland 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL) will now be able to access Tecartus® (brexucabtagene autoleucel; brexu-cel) through the public health system. Brexucabtagene autoleucel is the first CAR T-cell therapy to be reimbursed in Ireland for this patient population.
Acute lymphoblastic leukaemia (ALL) is an uncommon acute haematological malignancy, representing approximately 11% of all leukaemias in Ireland.1 While advances in chemotherapy and targeted immunotherapies have improved overall survival, relapsed or refractory (r/r) adult ALL is associated with “poor outcomes”.2
Julian Cole, Executive Director of Medical Affairs at Gilead Sciences, said, “This approval marks a major milestone for those aged 26 or more with relapsed or refractory ALL. Brexucabtagene autoleucel is now available to eligible patients offering a personalised and important treatment option where few options existed. We’re proud to help bring this innovation to patients who need it.”
The approval is supported by data from the pivotal ZUMA-3 single-arm trial in adult patients with relapsed or refractory B-precursor ALL.3
CAR T-cell therapies are individually made starting from a patient’s own white blood cells, called T-cells. The cells are collected through a process similar to donating blood platelets or plasma and sent to specialised manufacturing facilities where they are engineered to target the patient’s cancer, expanded and then returned to the hospital for infusion back into the patient.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information
1 NCCP National Haemato-oncology Adult Patient Pathway: Acute Lymphoblastic Leukaemia (ALL) / Acute Lymphoblastic Lymphoma (LBL) V3 / September 2024. Available at:
https://www.hse.ie/eng/services/list/5/cancer/profinfo/medonc/haemato-oncology-patient-pathways/all-patient pathway.pdf Last accessed: November 2025
2 van den Berg, J., Meloni, C., Halter, J., Passweg, J. R., & Holbro, A. (2025). The Changing Role of Allogeneic Stem Cell Transplantation in Adult B-ALL in the Era of CAR T Cell Therapy. Current oncology (Toronto, Ont.), 32(3), 177. Available at: https://doi.org/10.3390/curroncol32030177 Last accessed: November 2025 3 KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study Shah, Bijal D et al. The Lancet, Volume 398, Issue 10299, 491 – 502. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01222-8/abstract Last accessed: November 2025