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|Articles|October 19, 2022
Post-Transplant Lymphoproliferative Disease Treatment Receives Marketing Authorization Recommendation from EMA
Author(s)BioPharm International Editors
Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.
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The European Medicines Agency (EMA) announced on Oct. 14, 2022 that it would recommend a marketing authorization for Atara Biotherapeutics’ Evallo (tabelceleucel) for the treatment of patients with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (R/R EBV+ PTLD). Tabelceleucel would be the first treatment indicated for the condition, which occurs because of immunosuppressive medicines taken following either solid organ or bone marrow transplantation. The most common variant is associated with EBV.
According to an EMA press release, tabelceleucel is a T-cell–based therapy that targets and eliminates infected cells. The T-cells are mixed with B-cells from the same donor that has been infected with EPV so that the T-cells recognize infected B-cells. When given to the patient, this allows them to attack and kill the patient’s own infected B-cells and help control cancers associated with the virus.
EMA based its recommendations on the results of an ongoing multicenter, Phase III, single-arm, open-label clinical trial investigating its efficacy in 43 patients with R/R EBV+ PTLD who had received at least one prior therapy. Approximately half of the treated subjects achieved partial or complete remission, while a significant number responded to the treatment with a durable response of six months or more without disease signs or symptoms post-treatment.
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