Grandbrothers
Atara Biotherapeutics (NASDAQ:ATRA) announced Wednesday that the U.S. Food and Drug Administration (FDA) granted priority review for a marketing application targeted at its lead asset, tabelecleucel (tab-cel), for a post-transplant condition.
Atara’s (ATRA) biologics license application (BLA) is aimed at the use of tab-cel as a monotherapy late-line option for Epstein-Barr virus-positive post-transplant lymphoproliferative disease.
The regulator has granted January 15, 2025, as the target action date for its decision, following which the company and its partner Pierre Fabre Laboratories plan to launch the product early next year.
There are no FDA-approved therapies for EBV-positive PTLD, an immune condition characterized by a poor survival rate in patients who undergo organ transplantation.
“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 Atara (ATRA) CEO Pascal Touchon.
