Yescarta® (axicabtagene ciloleucel) - risk of cerebral oedema in patients with primary mediastinal B cell lymphoma

A Dear Healthcare Professional Letter has been issued by Gilead Sciences Singapore Pte. Ltd. to inform healthcare professionals of the possible increased risk of cerebral oedema, which may progress rapidly with potentially fatal outcomes in patients with primary mediastinal B cell lymphoma (PMBCL) treated with Yescarta® (axicabtagene ciloleucel). Cerebral oedema is a known risk of CAR-T therapy. The underlying mechanism of this risk is not known and may involve disease biology, anatomical location (large mediastinal mass), prior therapy, and/or other factors. The cerebral oedema reporting rate to Gilead for PMBCL is 1.4% (0.9% fatal) compared with 0.2% (0.1% fatal) in Diffuse Large B Cell Lymphoma (DLBCL).  Cerebral oedema may evolve as a manifestation of Immune-Effector Cell Associated Neurotoxicity Syndrome (ICANS) and may develop rapidly following mild neurologic symptoms. The aetiology of cerebral oedema, independent of CAR-T therapy, is not fully understood. Healthcare professionals are advised to consider increasing the frequency of monitoring for ICANS in PMBCL patients during the first 7-14 days of Yescarta® therapy and to initiate prompt treatment for ICANS per applicable guidelines, with prompt evaluation and consultation if cerebral oedema is suspected. Please refer to the letter for details.

Healthcare professional, Industry member, Cell, Tissue and Gene Therapy Products
Published:

Dear Healthcare Professional Letters

12 Nov 2025

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.