| Clinical data | |
|---|---|
| Trade names | Ebvallo |
| Other names | ATA129 |
| Routes of administration | Intravenous |
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Tabelecleucel, sold under the brand nameEbvallo, is amedication used for the treatment ofEpstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).[2][3] Tabelecleucel is anallogeneic, EBV-specificT-cell immunotherapy which targets and eliminates EBV-infected cells in ahuman leukocyte antigen (HLA)-restricted manner.[2] It is made of cells of the immune system called T-cells that have been taken from the recipient (allogeneic) and are then mixed with EBV-infected B-cells from the same donor.[2]
The most common side effects include fever, diarrhea, fatigue, nausea (feeling sick), anemia (low red blood cell count), reduced appetite, hyponatremia (low sodium levels in the blood), abdominal pain, low white blood cell count, including neutrophils (white blood cells that fight infections), elevated blood levels of aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase (indicators of potential liver damage), constipation, hypoxia (low blood oxygen levels), dehydration, hypotension (low blood pressure), nasal congestion, and rash.[1]
Tabelecleucel was approved for medical use in the European Union in December 2022.[1]
Tabelecleucel isindicated as monotherapy for treatment of people aged two 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.[1]
People who have undergone organ transplantation are routinely treated withimmunosuppressive drugs to preventtransplant rejection. As a result of the treatment, some people developEpstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (PTLD) in which white blood cells become infected with EBV and which in turn triggers excessive division of those cells. PTLD is initially non-cancerous, but can progress to cancerousHodgkin lymphoma.First-line treatments of PTLD include monoclonal antibodies such asrituximab andchemotherapy if cancer has developed.[4][5][6]
The most common side effects arefever,diarrhea, tiredness, feeling sick, low levels of red blood cells, decreased appetite and low blood sodium levels.[3]
The EMA recommendation is based on the results of an ongoingmulticenter,phase III, single-arm,open-label clinical trial.[2] The study investigated the efficacy and safety of tabelecleucel in 43 participants with relapsed/refractory EBV+ PTLD who had received at least one prior therapy.[2]
On 13 October 2022, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the medicinal product Ebvallo, intended for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).[2] As Ebvallo is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies.[2] The applicant for this medicinal product is Atara Biotherapeutics Ireland Limited.[2] Tabelecleucel was approved for medical use in the European Union in December 2022.[1][7]
