FDA issued a second Complete Response Letter (CRL) in January 2026 rejecting Ebvallo (tabelecleucel) for EBV+ PTLD in patients ≥2 years old after prior therapy, citing insufficient evidence of effectiveness despite prior alignment on single-arm ALLELE trial data.
First CRL in January 2025 was solely due to manufacturing issues, resolved in resubmitted BLA accepted July 2025; second CRL reversed prior FDA stance on trial adequacy after 5+ years of discussions.
Pierre Fabre requested urgent Type A meeting with FDA to address rejection and seek accelerated approval path; Atara committed to Expanded Access Program.
Ebvallo approved in EU, UK, Switzerland since 2022; supported by data from >430 patients showing 48.8% objective response rate.
Reports highlight FDA internal inconsistencies under new CBER leadership (Vinay Prasad), with prior reviewers deeming data sufficient except for manufacturing.
No direct evidence of FDA reconsideration as of May 2026; uniQure not mentioned in Ebvallo context but flagged in query as potential next FDA rejection risk amid shifting rare disease guidance.