ZALMOXIS (genetically modified T lymphocytes), antineoplastic

ZALMOXIS has been granted a marketing authorisation for adjuvant treatment during haplo-identical haematopoietic stem cell transplantation (HSCT) in adults presenting with high-risk malignant blood disorders.

ZALMOXIS is produced from a donor’s T lymphocytes, that are genetically modified ex vivo by transduction with a retroviral vector expressing an HSV-TKMut2 suicide gene. This suicide gene renders the transduced T lymphocytes sensitive to ganciclovir. In the event of graft-versus-host disease (GvHD), ganciclovir/valganciclovir destroys the T lymphocytes causing the GvHD.

ZALMOXIS is used for post-graft adjuvant treatment and is administered 3 to 7 weeks after transplantation, in the absence of spontaneous immune reconstitution and/or of GvHD.

Considering the limited efficacy data, and failing any comparative data relative to the reference strategy for haplo-identical transplantation, ZALMOXIS has no role in the management strategy of haplo-identical HSCT in adults presenting with high-risk malignant blood disorders.