Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel
Atara and partner Pierre Fabre announced that the FDA agreed a single-arm study with historical controls could support a future marketing application for tabelecleucel. Pierre Fabre intends to submit an updated dataset with additional patients and longer follow-up from the Phase 3 ALLELE study as part of the BLA resubmission plan.
Key figures
- Drug Name
- tabelecleucel (tab-cel)
- Phase Of Trial
- Phase 3
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