FDA Accepts Atara Biotherapeutics’ Resubmitted Tab-cel BLA
The FDA assigned a Class 2 review and a PDUFA target action date of March 31, 2027, for tabelecleucel as monotherapy for EBV+ PTLD. Approval would trigger a $31.0 million milestone under Atara’s Pierre Fabre deal.
Atara said the FDA accepted its resubmitted BLA for tabelecleucel as a monotherapy for EBV+ PTLD. The agency assigned the application a Class 2 review and set a PDUFA target action date of Mar 31, 2027. 0M milestone payment under Atara’s deal with Pierre Fabre.