Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration
The FDA accepted Atara's partner Pierre Fabre's resubmitted Biologics License Application for tabelecleucel as monotherapy for EBV+ post-transplant lymphoproliferative disease in patients two years and older. The BLA carries a Class 2 Resubmission PDUFA target action date of March 31, 2027; if approved, Tab-cel would be the first U.S. therapy for EBV+ PTLD. Upon approval, Atara would receive a $31 million milestone payment plus double-digit tiered royalties on net sales and additional commercial milestones.
Key figures
- Drug Name
- tabelecleucel (Tab-cel)
- Pdufa date
- March 31, 2027
- Prior crl date
- January 9, 2026
- Milestone payment on approval
- $31 million
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