European Commission Approves Atara’s Ebvallo as First Ever Therapy for Adults and Children with EBV+ PTLD

The European Commission granted marketing authorization for Atara Biotherapeutics’ Ebvallo, an allogeneic T-cell immunotherapy, 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.

Ebvallo was approved for patients with Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy, which for solid organ transplant patients, includes chemotherapy unless chemotherapy is inappropriate.

The approval follows a positive opinion in October by the Committee for Medicinal Products for Human Use of the European Medicines Agency 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. In this study, Ebvallo demonstrated a favorable risk-benefit profile.

“The approval of Ebvallo in Europe is a medical breakthrough for patients with significant unmet need,” said Pascal Touchon, president and CEO 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 Ebvallo Marketing Authorization Application 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.

Ebvallo (tabelecleucel) 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.

Photo: Pascal Touchon, president and CEO of Atara

Author: Rare Daily Staff