Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for Ebvallo (tabelecleucel).
The letter, received Jan. 9, said the FDA no longer considers the single-arm ALLELE trial adequate to support accelerated approval for patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease who are 2 years of age or older and have received at least one prior therapy, according to a Jan. 12 company news release.
Atara had resubmitted the BLA in 2025 after resolving a good manufacturing practice compliance issue identified in the first CRL dated Jan. 15, 2025. The latest letter did not raise safety concerns.
In November 2025, Atara transferred the BLA to Pierre Fabre Pharmaceuticals. A Type A meeting to discuss next steps toward potential approval with the FDA is expected within 45 days.
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