Atara Biotherapeutics (Atara) and Pierre Fabre have announced that the European Commission (EC) has granted marketing authorisation for Ebvallo (tabelecleucel) as a monotherapy for adult and paediatric patients two years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
The authorisation is specifically for those who have either received at least one prior therapy, or for solid organ transplant patients, for whom prior therapy includes chemotherapy unless chemotherapy is inappropriate.
The EC’s approval is based on a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in October and is applicable to all 27 EU member states plus Iceland, Norway and Liechtenstein.
The CHMP’s positive opinion is supported by results taken from the pivotal phase 3 ALLELE study, in which Ebvallo showed a favourable risk-benefit profile.
“The approval of Ebvallo in Europe is a medical breakthrough for patients with significant unmet need,” said Pascal Touchon, president and chief executive officer of Atara.
He added: “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 haematologic malignancy that is a result of immunosuppression as it occurs after transplantation when a patient’s T-cell immune response is compromised.
The condition can affect patients who have undergone solid organ transplant (SOT) or allogeneic haematopoietic cell transplant (HCT), and the critical need for new therapy channels is highlighted by poor median survival results of 0.7 months and 4.1 months for HCT and SOT, respectively, which is reported in EBV+ PTLD patients for whom standard of care was unsuccessful.
According to a previously announced Licence Agreement with Atara, Pierre Fabre will oversee all commercialisation and distribution activities in Europe and select other markets, as well as medical and regulatory activities following the transfer of the Ebvallo Marketing Authorisation 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, chief executive officer of Pierre Fabre, Atara’s commercialisation 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, haematology and rare diseases.”
Ebvallo has orphan designation in Europe, which is reserved for therapies treating life-threatening or chronically debilitating diseases that are rare – affecting not more than five in 10,000 people in the EU.