Atara announces $20M milestone from Pierre Fabre amid filing of tab-cel BLA

Atara Biotherapeutics announced that the U.S. Food and Drug Administration or FDA has accepted the filing of its Biologics License Application or BLA, or tabelecleucel, tab-cel, indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease or EBV+ PTLD, who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting. The BLA has been granted Priority Review with a Prescription Drug User Fee Act PDUFA target action date of January 15. “The acceptance of the tab-cel BLA is a significant milestone towards making this first-of-its-kind treatment available to patients in the U.S.,” said Pascal Touchon, President and Chief Executive Officer of Atara. “The FDA’s granting of priority review highlights the high unmet need in EBV+ PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate. We continue to work closely with the Pierre Fabre Laboratories team to help prepare for the potential launch in the U.S. in early 2025, along with the potential label expansion multicohort Phase 2 EBVision trial.”