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Ready-to-use T cell therapy enters the regulatory review stage for the first time, significantly improving patient survival

 Last Update: 2022-01-12
 Source: Internet
 Author: User

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On November 30, 2021, Atara Biotherapeutics announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for the T cell immunotherapy tabelecleucel (tab-cel) for the treatment of EB virus (EBV) related Post-transplant lymphoproliferative disease (EBV+PTLD)

EBV+PTLD is a type of lymphoma, a serious blood cancer, which may occur after solid organ transplantation (SOT) or allogeneic hematopoietic cell transplantation (HCT)

Tab-cel is a ready-to-use allogeneic T cell immunotherapy

This application is based on positive data obtained from an ongoing phase 3 clinical trial.

▲Tab-cel Phase 3 clinical trial results (picture source: Atara Biotherapeutics official website)

Reference materials:

[1] European Medicines Agency (EMA) Validates Atara Biotherapeutics' Marketing Authorization Application for Tabelecleucel for the Treatment of Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease.

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