Shulou(Shulou.com)11/24 Report--

CTOnews.com, December 20-the European Commission (EC) has granted Ebvallo (tabelecleucel) a marketing license for monotherapy, approved by the European Drug Administration (EMA) Commission for Medicines for Human use (CHMP), for all 27 EU member states, as well as Iceland, Norway and Liechtenstein. According to officials, this is the first allogeneic T cell immunotherapy approved in the world.

Atara, a US biotechnology company, and Pierre Fabre, a French drug company, announced yesterday that the European Commission had approved its Ebvallo (tabelecleucel) as a monotherapy for post-transplant lymphoproliferative diseases (EBV+PTLD) associated with Epstein-Barr virus, for children and adults over the age of 2 who had received at least one previous treatment. CTOnews.com warns that for patients with solid organ transplants, chemotherapy will be included in previous treatments unless they are really not suitable for chemotherapy.

To put it simply, EBV+ PTLD is a rare, acute and potentially fatal hematological malignant disease, which mainly occurs when the T cell immune response of patients after organ transplantation is affected by immunosuppression, so patients who have received solid organ transplantation (SOT) or allogeneic hematopoietic cell transplantation (HCT) may be affected.

According to the press release, in EBV+ PTLD cases where conventional treatment fails, the median survival time of HCT and SOT is 0.7 months and 4.1 months, respectively, so we urgently need a new treatment.

Eric Ducournau, CEO of Pierfarb, said: "Ebvallo represents an important moment in cell therapy and a breakthrough for EBV+ PTLD patients in Europe." Pierfarb's product portfolio in oncology, hematology and rare diseases will be strengthened. "

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