Atara partner Pierre Fabre resubmits tabelecleucel BLA to FDA
ATRA•Pierre Fabre Pharmaceuticals resubmitted the tabelecleucel BLA to the FDA for relapsed/refractory EBV+ PTLD in SOT or HCT patients. FDA approval would trigger a $31 million milestone payment to Atara, which expects a revised PDUFA date after the FDA sets its review timeline.
1. BLA resubmitted
Pierre Fabre Pharmaceuticals resubmitted the tabelecleucel BLA to the FDA for relapsed/refractory EBV+ PTLD in SOT or HCT patients. Atara Biotherapeutics expects to provide a revised PDUFA date once the FDA sets the review timeline. FDA approval would trigger a $31 million milestone payment to Atara under its commercialization deal with Pierre Fabre.
