Registration for reimbursement and approval to communities published in the Official Journal of July 4, 2025
PARIS And Castres, France, July 7, 2025 / Prnewswire/ – The Pierre Fabre laboratories announce the marketing in France of EBVALLO® (TabeLECLUCEL), allogenic immunotherapy with T lymphocytes available on demand and specifically selected for each patient. (1,2)
EBVALLO® (TabeLECLEUCEL) is a 2nd line treatment and more indicated in monotherapy in the treatment of adult and pediatric patients aged 2 years and more suffering from a post-transplantation and positive lymphoproliferative disease at the recurrent or refractory EPSTEIN-BARR virus (LPT EBV+) which received at least an earlier treatment. For patients who have received a solid organ transplant, the previous treatment includes chemotherapy, unless it is inappropriate. EBVALLO® (TabeLECLEUL) is an allogenic immunotherapy produced from T lymphocytes of healthy donors of EBV. (2)
“Post-transplantation EBV+ lymphoproliferations are serious pathologies, often associated with an unfavorable prognosis, in particular in the event of recurrence or resistance to conventional first-line treatments. The introduction of the TabeLECLUCEL represents an important advance for relapse or refractory patients, often so far in therapeutic dead end. This innovative therapy offers real hope to clinicians and opens up to the previously limited perspectives for the patients concerned. “Said Dr. Sylvain Choquethead of the clinical hematology service of the Pitié-Salpêtrière Hospital (AP-HP).
“In pediatric patients over 2 years old, post-transplantation EBV+ lymphoproliferations can evolve quickly to severe forms, bringing the vital prognosis into play. TabelecleuceUl is a major therapeutic advance, by offering a targeted and innovative option. This allogenic cell therapy opens up to the past very limited perspectives, and gives hope to families and nursing teams. “Said Professor Jean-Hugues Dalle, head of the pediatric hemato-immunology service at the Robert Debré university hospital (AP-HP).
“The reimbursement of EBVALLO® (TabeLECLUCEL) is a major step for French patients suffering from this rare, acute and potentially deadly disease,” said Dominique GougeonDirector of the Operational Unit Oncology Innovation within the Pierre Fabre laboratories. “Ebvalo® was recognized in 2024 by the Galien International Prize which rewards each year a major therapeutic innovation. This European recognition echoes the Galien France Prize Received in 2023, greeting from the outset the major therapeutic innovation that EBVALLO® represents and we are delighted that French patients can benefit from it. EBVALLO® meets an unmet medical need, improving the prospects for the treatment of people affected by this disease. “
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