Pierre Fabre to commercialize and distribute the first approved allogeneic T-cell immunotherapy in Europe following transfer of the European Commission Marketing Authorization of EBVALLO® (tabelecleucel)
CASTRES, France & THOUSAND OAKS, Calif. USA – February 8, 2023 – Pierre Fabre and Atara Biotherapeutics, Inc. (Nasdaq: ATRA) today announced the transfer of the European Commission (EC) marketing authorization (MA) for EBVALLO® (tabelecleucel) for patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) from Atara to Pierre Fabre. From today, Pierre Fabre will lead all commercialization, distribution, medical and regulatory activities in Europe, Middle East, Africa and other selected markets. Pierre Fabre is planning to launch EBVALLO® in the first European countries during quarter one of 2023.
“We are delighted that, at Pierre Fabre, we will now be able to make EBVALLO® available to patients with Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) as quickly as possible,” said Eric Ducournau, CEO of Pierre Fabre. “As a Company, we are passionate in accelerating the development and delivery of ground-breaking treatments for solid tumors, hematologic malignancies and rare diseases. 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.” To know more
