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Atara Biotherapeutics’ Ebvallo™ (tabelecleucel) Receives European Commission Approval as First Ever Therapy for Adults and Children with EBV+ PTLD
Only Approved Therapy for EU Patients with Rare and Potentially Deadly Cancer Facing Median Survival of Only a Few Months Represents First Approval of an
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nOnly Approved Therapy for EU Patients with Rare and Potentially Deadly Cancer Facing Median Survival of Only a Few Months\n\nRepresents First Approval of an Allogeneic T-Cell Immunotherapy Globally\n\nPierre Fabre to Lead Commercialization and Distribution Activities in Europe\n\n THOUSAND OAKS, Calif. & CASTRES, France--(BUSINESS WIRE)--\nAtara 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 the 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.\n\nThe 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 3 ALLELE study.1 In this study, EbvalloTM demonstrated a favorable risk-benefit profile.\n\n“The approval of EbvalloTM in Europe is 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 marks a historic moment for Atara, our European partner, Pierre Fabre, and for the broader cell therapy field.”\n\nEBV+ 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 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.\n\nUnder a previously announced License Agreement with Atara, Pierre Fabre will lead all commercialization and distribution activities ...