Atara and Pierre Fabre Secure FDA Type A Meeting for Ebvallo After Second CRL, Amid Leadership Shifts
Pierre Fabre and Atara received a second FDA Complete Response Letter (CRL) on January 10, 2026, for Ebvallo (tabelecleucel) targeting EBV-positive post-transplant lymphoproliferative disease (PTLD), citing issues with the single-arm ALLELE trial despite prior FDA alignment.
First CRL in January 2025 was due to manufacturing issues, now resolved; second CRL reversed prior acceptance of trial design for accelerated approval.
Pierre Fabre requested and was granted a Type A meeting with FDA to address CRL concerns and discuss resubmission path, with Atara supporting via briefing book including updated ALLELE data and European post-marketing evidence.
FDA Commissioner Marty Makary and deputy Vinay Prasad implicated in regulatory shifts; query references 'another shot' a week after Prasad's departure, suggesting potential opportunity amid leadership change.
Ebvallo approved in Europe in 2022; Atara eligible for $31M milestone upon FDA approval, plus $15M commercial milestone; therapy offered via Expanded Access Program.