Will this Atara Biotherapeutics drug be the first approved therapy of its kind? 

EBV virus

Atara Biotherapeutics has submitted a Biologics License Application (BLA) for Tabelecleucel (Tab-cel), a for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) with the US Food and Drug Administration (FDA). There are currently no FDA approved therapies in this treatment setting. 

It is indicated as monotherapy for treatment of adult and paediatric patients two years of age and older with EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.  

“Patients facing relapsed or refractory EBV+ PTLD have limited therapeutic options and their survival is unfortunately often measured in weeks or months. Filing of the BLA is a significant step towards making Tab-cel available to patients in the US. We congratulate our partner ATARA on this significant achievement and are now focused on preparing for the potential FDA review and approval,” said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals, the new Pierre Fabre Medical Care subsidiary in the UnUS.  

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells. The BLA is supported by data covering more than 430 patients treated with Tab-cel across multiple life-threatening diseases including the latest pivotal ALLELE study data Tab-cel in adults and children two years of age and older with relapsed or refractory EBV+ PTLD following solid organ transplant (SOT) or haematopoietic cell transplant (HCT). 

Prior approval for Tab-cel

Tab-cel was granted marketing authorisation under the brand name Ebvallo in December 2022 by the European Commission (EC). Marketing authorisation was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024.  

In all three territories, Ebvallo is indicated as monotherapy for the treatment of adult and paediatric patients two 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.   

Eric Ducournau, CEO of Pierre Fabre Laboratories, said: “Since EBVALLO’s transfer of marketing authorisation in Europe to Pierre Fabre a year ago, patients have already been treated in Germany and Austria, and benefited from the treatment through Early Access Program in place in other European countries.” 

Megan Thomas, Multimedia Editor, DDW

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