Atara Biotherapeutics' Ebvallo® (tabelecleucel) Receives European Commission Approval as First Ever Therapy for Adults and Children with EBV+ PTLD
THOUSAND OAKS, Calif. and CASTRES, France, Dec. 19, 2022 /PRNewswire/ -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), and Pierre Fabre today 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 of Ebvallo® in Europe represents a medical breakthrough for patients with significant unmet need," said Pascal Touchon, President and Chief Executive Officer of Atara.
- "As the first allogeneic, or donor-derived, T-cell immunotherapy to receive approval from any regulatory agency in the world, this represents a historic moment for Atara, our European partner, Pierre Fabre, and for the broader cell therapy field."
- 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.
- Improving patients' lives is our mission and we will never stop working to bring transformative therapies to those in need.