Today Atara announced that it submitted a Biologics License Application (BLA) to the U.S. FDA for tabelecleucel (tab-cel®) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus (#EBV) positive post-transplant lymphoproliferative disease (#PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. This represents the first-ever #allogeneic #Tcell therapy BLA submission to the FDA, and if approved, tab-cel would be the first approved therapy in the U.S. for EBV+ PTLD. Read more about this significant milestone for Atara: https://bit.ly/4dL7elE
Daniel C. Lee
1mo
Congratulations to the teams involved! Big milestone achievement!
Chirag Khatiwala
1mo
It has been a long time coming but massive congratulations to the team!
Congratulations to the entire Atara team who I know worked tirelessly to make this happen! So great to see tab-cel finally on the road to meeting the tremendous unmet need in EBV+ PTLD!!
David Hambly
1mo
Great job everyone! This took a lot of perseverance but shows patients just how dedicated we are to being lifesaving meds to patients. I recall fondly working with the Atara team towards this and celebrate all who helped move this down the long road.
Congratulations and a HUGE thanks to all the Atarians for the relentless efforts over the many years, to achieve this incredible milestone for US patients!
Amie Krause
1mo
Congratulations team!
Sang Yoon, MBA
1mo
Wonderful! Congratulations to the entire team, such a monumental achievement
Troy Fugate
1mo
Congratulations
Shanna M.
1mo
Atara Biotherapeutics The BLA filing status box is FINALLY blue! 💙 Congratulations!🎉
Chief Executive Officer
1moCongratulations team!