Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA
There are no FDA approved therapies in this treatment setting.
- There are no FDA approved therapies in this treatment setting.
- Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation.
- In addition, Pierre Fabre is reimbursing Atara for expected tab-cel global development costs through the BLA transfer and purchasing tab-cel inventory through the manufacturing transfer date.
- Atara is also eligible to receive double-digit tiered royalties on net sales of tab-cel in the U.S. and remaining global commercial markets referenced above.