Overview
- The FDA’s Jan. 9 complete response letter states the single-arm ALLELE study is no longer considered adequate to support accelerated approval for EBV-positive post-transplant lymphoproliferative disease after prior therapy in patients two years and older.
- Regulators confirmed that good manufacturing practice concerns from the first 2025 CRL have been satisfactorily addressed.
- Atara reported that the latest letter did not raise new safety concerns related to tabelecleucel (Ebvallo).
- The biologics license application was transferred to Pierre Fabre in November 2025, and the company plans to request a Type A meeting it expects within 45 days to discuss next steps.
- Atara shares fell about 53% on Monday following disclosure of the new regulatory setback.