Guess the Therapy Answer January 7, 2026

Which Epstein-Barr virus (EBV)–specific T-cell immunotherapy is currently approved in the European Union for EBV-positive posttransplant lymphoproliferative disease (EBV+ PTLD)?

Answer: tabelecleucel (tab-cel; marketed as Ebvallo)

See below for further reading on tab-cel:

FDA Accepts Atara Biotherapeutics’ Resubmission of BLA for Tabelecleucel

The FDA has accepted Atara Biotherapeutics' resubmission of a biologics license application (BLA) for allogeneic EBV–specific T-cell immunotherapy tab-cel, which is intended to treat patients 2 years or older with EBV+ PTLD who have received at least 1 prior therapy.¹

Notably, the BLA resubmission was accepted with priority review and the Prescription Drug User Fee Act (PDUFA) target action date has been set for January 10, 2026. Atara pointed out that as of now there are no therapies approved by the FDA for the aforementioned treatment setting.

FDA Issues CRL for Atara Biotherapeutics’ BLA for T-Cell Immunotherapy Tabelecleucel for EBV+ PTLD

The FDA has issued a complete response letter (CRL) to Atara Biotherapeutics regarding its BLA for tab-cel, an allogeneic EBV-specific T-cell immunotherapy, which is under evaluation for the treatment of patients with relapsed/refractory EBV+ PTLD.

Notably, the CRL was related to issues with a standard prelicense inspection of a third-party manufacturer for tab-cel rather than to any concerns regarding the efficacy and safety data contained within the BLA. The manufacturing process itself was not implicated, and the FDA has not requested additional clinical trials for tab-cel.