EMA Approves Updated Safety Information for Kite’s YESCARTA and TECARTUS Allow for a More Flexible Post-Infusion Management Approach
April 24, 2026 – Biotechnology, Clinical Trials, Other, Pharmaceutical – CAR T-cell, EMA, Gilead Sciences, Kite Oncology, Kite Pharma, Summary of Product Characteristics
Update Enhances Convenience and Flexibility for Healthcare Professionals and Eligible Patients, while Maintaining CAR-T Safety Management Standards
24 April 2026 — Stockley Park, UK — Gilead and Kite Oncology today announced that the European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus® (brexucabtagene autoleucel) supporting a more flexible, evidence-based post infusion management approach.
The revised SmPC introduces several important changes that maintain Kite’s established CAR T safety management standards while offering greater flexibility in post-infusion care. These include a reduction in the required patient proximity to a qualified treatment center or appropriately trained clinical facility from four weeks to two weeks, and a revision of driving restrictions from eight weeks to a minimum of four weeks post-infusion. Additionally, it provides increased flexibility by allowing appropriately trained clinical facilities to assume responsibility for post-discharge monitoring and permits clinical discretion in the prophylactic administration of corticosteroids for patients identified to be at increased risk of severe immune-mediated adverse reactions.
“The updated EU labels for axicabtagene ciloleucel and brexucabtagene autoleucel represent a significant step forward in optimising the management of patients receiving CAR T-cell therapy,” said Dan Tovar, Head of Medical Affairs Cell Therapy, Australia, Canada and Europe (ACE) Region. “By advancing real-world insights and advocating for systemic change, we are working to ease the burden of post-infusion care for patients, caregivers and healthcare professionals.”
The EMA decision is based on a comprehensive review of the totality of evidence, including pivotal clinical trial data supplemented by additional supportive data from ZUMA-1 Cohort 4 and 6 and ZUMA-24 studies, coupled with extensive post-marketing real-world experience. This evidence collectively demonstrates that these updates maintain the safety management standards of Kite’s CAR T-cell therapy portfolio while enhancing practicality for patients and supporting a more flexible approach to toxicity management.
“This EMA’s decision is a positive step for patients, directly addressing some of the practical challenges they face post-infusion,” said, Dr Anna Sureda, Head of the Clinical Hematology Service, Catalan Institute of Oncology. “This move, supported by extensive real-world data, means improved quality of life and for people treated across Europe, all while maintaining unwavering commitment to patient safety.”
The EU label update follows recent regulatory milestones for axicabtagene ciloleucel and brexucabtagene autoleucel in the United States, reflecting continued evolution of the evidence base supporting these therapies. These include the FDA’s February 2026 approval to update axicabtagene ciloleucel’s prescribing information by removing previous Limitations of Use in relapsed or refractory Primary CNS Lymphoma, and its June 2025 decision to remove the Risk Evaluation and Mitigation Strategy (REMS) requirements for both axicabtagene ciloleucel and brexucabtagene autoleucel.
About Gilead and Kite Oncology
Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer. Visit: gilead.com.
