17 novembre 2022

Pierre Fabre; Atara: CHMP Recommends Approval of Atara Biotherapeutics’ EbvalloTM (tabelecleucel) for the Treatment of Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease

SAN FRANCISCO and CASTRES, France, Oct. 14, 2022 /PRNewswire/ — Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) approval of EbvalloTM (tabelecleucel) as a monotherapy for 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. To know more