Tabelecleucel (Ebvallo)

Mechanism of action

From the NCI Drug Dictionary: Allogeneic cytotoxic T lymphocytes (CTLs) selective for the tumor-associated antigens (TAAs) expressed by the Epstein-Barr virus (EBV), with potential immunostimulating and antineoplastic activities. Upon administration, and after hematopoietic cell transplants (HCT) or solid organ transplants (SOT), or during certain other immunocompromised states, tabelecleucel targets and binds to EBV-associated antigens expressed on EBV-infected cells. This results in lysis of EBV-infected cells and prevents growth of EBV-associated cancer cells.

Diseases for which it is used

• Post-transplant lymphoproliferative disorder

History of changes in EMA indication

• 2022-12-16: Initial authorization as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Also known as

• Code name: ATA-129
• Generic name: EBV-CTLs
• Brand name: Ebvallo, Tab-cel