EU approves Ebvallo in refractory Epstein–Barr virus positive post–transplant lymphoproliferative disease
Atara Biotherapeutics and Pierre Fabre announced that the European Commission (EC) has granted marketing authorization for Ebvallo (tabelecleucel) as a monotherapy for treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein–Barr virus positive post–transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy
For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.
The approval follows a positive opinion in October by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. The CHMP positive opinion is based on results from the pivotal Phase III ALLELE study. In this study, Ebvallo demonstrated a favorable risk-benefit profile.
EBV+ PTLD is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when a patient's T-cell immune response is compromised by immunosuppression. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic hematopoietic stem cell transplant (HCT). Poor median survival of 0.7 months and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients for whom standard of care failed, underscoring the significant need for new therapeutic options.
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