Pierre Fabre will commercialise and distribute the first approved allogeneic T cell immunotherapy in Europe following the transfer of the European Commission marketing authorisation of Ebvallo (tabelecleucel) from Atara Biotherapeutics.
Ebvallo is the only approved therapy for the treatment of relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) in the EU.
Pierre Fabre will lead all commercialisation, distribution, medical and regulatory activities in Europe, Middle East, Africa and other selected markets.
Pierre Fabre is planning to launch the drug in the first European countries during quarter one of 2023.
Eric Ducournau, CEO of Pierre Fabre, commented: “With Ebvallo being the only approved therapy for EU patients affected by EBV+ PTLD, this is a significant milestone for people diagnosed with this rare and potentially deadly cancer and an important step forward in our commitment to addressing clinical challenges with solutions once considered unimaginable.”
Approval in Europe
In December 2022 the EC granted marketing authorisation for Ebvallo as a monotherapy for the treatment of adult and paediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy.
The EC marketing authorisation was based on results from the pivotal Phase III ALLELE study and additional supportive studies.
Atara will continue to be responsible for the pivotal ALLELE study in PTLD and the Phase II multi-cohort study, which is evaluating Ebvallo in additional patient populations. Atara also retains full rights to Ebvallo in other major markets, including North America, Asia Pacific, and Latin America.
Pascal Touchon, President and Chief Executive Officer of Atara, said: “We are excited for Pierre Fabre to now bring this innovative new treatment to EBV+ PTLD patients in Europe who, until now, have had no approved therapeutic options and faced just a few weeks to a few months median survival.”