Atara Biotherapeutics' tab-cel BLA accepted for priority review by FDA; PDUFA Jan 15, 2025

Atara Biotherapeutics, Inc.

BLA for tabelecleucel (tab-cel) accepted for priority review to treat EBV+ PTLD in patients ≥2 years with ≥1 prior therapy.
PDUFA target action date set for January 15, 2025; no FDA-approved therapy currently exists for this indication.
BLA acceptance triggers $20M milestone payment from Pierre Fabre; up to $60M additional if FDA approves.
Supported by ALLELE study data showing 48.8% objective response rate (p<0.0001) and favorable safety profile.
Tab-cel already approved as Ebvallo in EU, UK, and Switzerland for relapsed/refractory EBV+ PTLD.

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