Atara Biotherapeutics

July 17, 2024

  • News

Today Atara announced that the FDA has accepted its Biologics License Application (BLA) and granted Priority Review with a January 15, 2025 hashtag#PDUFA date for tabelecleucel (tab-cel®) as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus (hashtag#EBV) positive post-transplant lymphoproliferative disease (hashtag#PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

If approved, tab-cel would be the first approved therapy in the U.S. for EBV+ PTLD. Read the press release for more: https://bit.ly/46bainx