PARSIPPANY, N.J., July 18, 2024 /PRNewswire/ -- Pierre Fabre Pharmaceuticals Inc. announces the acceptance by U.S Food and Drug Administration (FDA) of the Biologics License Application (BLA) and Priority Review of Tabelecleucel (Tab-cel®), 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.
Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
Atara Biotherapeutics’ Ebvallo™ (tabelecleucel) Wins Prix Galien International Award for Best Product for Orphan/Rare Diseases
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.
Pierre Fabre`s Ebvallo (tabelecleucel) Receives Approval in Europe
Pierre Fabre`s Ebvallo (Tabelecleucel) Approved In Europe
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)
Atara Biotherapeutics Ebvallo (tabelecleucel) Receives Approval in Europe