PMID- 37016096
OWN - NLM
STAT- MEDLINE
DCOM- 20230503
LR  - 20230509
IS  - 1179-2000 (Electronic)
IS  - 1177-1062 (Linking)
VI  - 27
IP  - 3
DP  - 2023 May
TI  - Tabelecleucel: First Approval.
PG  - 425-431
LID - 10.1007/s40291-023-00648-z [doi]
AB  - Tabelecleucel (Ebvallo(TM)) is an allogeneic Epstein-Barr virus (EBV)-specific 
      T-cell immunotherapy that targets and eliminates EBV positive (EBV(+)) cells in a 
      human leukocyte antigen (HLA) restricted manner. Tabelecleucel has been developed 
      by Atara Biotherapeutics under a license from Memorial Sloan-Kettering Cancer 
      Center (MSKCC) for the treatment of lymphoproliferative disorders (LPDs), 
      including rituximab relapsed/refractory EBV(+) post-transplant 
      lymphoproliferative disease (PTLD). Tabelecleucel was granted marketing 
      authorization under 'exceptional circumstances' on 16 December 2022 as 
      monotherapy for the treatment of adult and paediatric patients 2 years of age and 
      older with relapsed or refractory EBV(+) PTLD who have received at least one 
      prior therapy. For solid organ transplant patients, prior therapy includes 
      chemotherapy unless chemotherapy is inappropriate. This article summarizes the 
      milestones in the development of tabelecleucel leading to this first approval for 
      EBV(+) PTLD.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Keam, Susan J
AU  - Keam SJ
AD  - Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. 
      mdt@adis.com.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230405
PL  - New Zealand
TA  - Mol Diagn Ther
JT  - Molecular diagnosis & therapy
JID - 101264260
RN  - 4F4X42SYQ6 (Rituximab)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Child
MH  - Herpesvirus 4, Human
MH  - *Epstein-Barr Virus Infections/drug therapy
MH  - *Organ Transplantation/adverse effects
MH  - Rituximab/therapeutic use
MH  - *Lymphoproliferative Disorders/drug therapy
EDAT- 2023/04/05 06:00
MHDA- 2023/05/03 06:42
CRDT- 2023/04/04 23:25
PHST- 2023/03/21 00:00 [accepted]
PHST- 2023/05/03 06:42 [medline]
PHST- 2023/04/05 06:00 [pubmed]
PHST- 2023/04/04 23:25 [entrez]
AID - 10.1007/s40291-023-00648-z [pii]
AID - 10.1007/s40291-023-00648-z [doi]
PST - ppublish
SO  - Mol Diagn Ther. 2023 May;27(3):425-431. doi: 10.1007/s40291-023-00648-z. Epub 
      2023 Apr 5.