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Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA
CASTRES, France, May 20, 2024 /PRNewswire/ -- Pierre Fabre Laboratories today announce the submission by Atara Biotherapeutics (ATARA), a leader in T-cell immunotherapies, of Tabelecleucel (Tab-cel®) Biologics License Application for treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S Food and Drug Administration (FDA), indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with 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. There are no FDA approved therapies in this treatment setting.