Atara says FDA accepts resubmitted Tab-cel BLA, sets March 31, 2027 PDUFA date
ATRA•The FDA accepted the resubmitted application for Tab-cel to treat EBV+ PTLD in patients aged 2 and older, setting a March 31, 2027, target action date. Atara could receive a $31 million milestone if the treatment is cleared.
1. FDA sets review date
The FDA accepted the resubmitted BLA for tabelecleucel (Tab-cel) to treat EBV+ PTLD in patients aged 2 and older. The Class 2 resubmission has a PDUFA target action date of March 31, 2027. Partner Pierre Fabre Pharmaceuticals filed the resubmission, and Atara could receive a $31 million milestone if Tab-cel is cleared.
