Atara Biotherapeutics’ Ebvallo™ (tabelecleucel) Receives European Commission Approval as First Ever Therapy for Adults and Children with EBV+ PTLD
Represents First Approval of an Allogeneic T-Cell Immunotherapy Globally
Pierre Fabre to Lead Commercialization and Distribution Activities in Europe
THOUSAND OAKS, Calif. & CASTRES, France – 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 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.
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 3 ALLELE study.1 In this study, EbvalloTM demonstrated a favorable risk-benefit profile.
“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.”
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 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.
Under a previously announced License Agreement with Atara, Pierre Fabre will lead all commercialization and distribution activities in Europe and select other markets, in addition to medical and regulatory activities following the transfer of the EbvalloTM Marketing Authorization Application (MAA) from Atara to Pierre Fabre.
“Ebvallo™ represents a significant moment in the cell therapy space and a breakthrough for European patients with EBV+ PTLD,” said Eric Ducournau, CEO of Pierre Fabre, Atara’s commercialization partner in Europe. “We are proud and excited to bring this innovative therapy to the marketplace, which will reinforce Pierre Fabre’s portfolio in oncology, hematology, and rare diseases.”
EbvalloTM has orphan designation in Europe. Orphan designation is reserved for medicines treating life-threatening or chronically debilitating diseases that are rare (affecting not more than five in 10,000 people in the EU). Authorized orphan medicines benefit from ten years of market exclusivity, protecting them from competition with similar medicines with the same therapeutic indication, which cannot be marketed during the exclusivity period.
About Pierre Fabre
Pierre Fabre is a French healthcare company with over 35-years of experience in innovation, development, manufacturing and commercialization in oncology. Its portfolio includes several medical franchises and international brands, namely Pierre Fabre Oncology, Pierre Fabre Dermatology, Pierre Fabre Health Care, Eau Thermale Avène, Klorane, René Furterer, A-Derma, Darrow, Glytone, Naturactive and Pierre Fabre Oral Care. In 2021, Pierre Fabre posted 2.5 billion euros in revenues, 66% of which came from international sales in over 100 countries.
Established in the South-West of France since its creation, the group manufactures over 95% of its products in France and employs some 9,500 people worldwide. Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program receiving marketing authorization in Europe, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors).