Atara Biotherapeutics (ATRA) requests FDA Type A meeting on EBVALLO™

2026-04-01 22:08:05

Atara Biotherapeutics announced that its partner Pierre Fabre Pharmaceuticals has requested a Type A meeting with the FDA to discuss tabelecleucel (EBVALLO™). This meeting follows a Complete Response Letter from the FDA for the Biologics License Application, and a briefing book has been submitted to address the issues raised, arguing the sufficiency of the ALLELE study and presenting updated efficacy and post-marketing data. The company aims for a constructive discussion to find a path forward for tabelecleucel for patients with EBV+ PTLD.

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