PRAC Safety Update – John Cunningham (JC) virus reactivation in CAR-T treated patients
During the EMA Pharmacovigilance Risk Assessment Committee (PRAC) meeting held from July 7 to 10, 2025, safety signals were adopted for the following CAR-T therapies:
- Kymriah
- Abecma
- Carvykti
PRAC noted that reactivation of the John Cunningham (JC) virus, which can lead to progressive multifocal leukoencephalopathy (PML), has been reported in patients treated with these CAR-T therapies, particularly those who had previously received other immunosuppressive medications.
Background information:
Multiple myeloma (MM) patients, especially those undergoing treatment with immunomodulatory therapies or stem cell transplant, are at increased risk for JC virus (JCV) reactivation and subsequent development of Progressive Multifocal Leukoencephalopathy (PML). PML, a rare and often fatal brain infection, results from the reactivation of the JC virus, which typically remains dormant in healthy individuals.