Atara: EMA Grants Accelerated Assessment To Tab-cel - Quick Facts

(RTTNews) - Atara Biotherapeutics, Inc. (ATRA) said the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted accelerated assessment to the company's lead product candidate, tabelecleucel, for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Atara said MAA for tab-cel is on track for submission in November 2021. The company expects a decision regarding approval in the second half of 2022.

Tab-cel also has Orphan Drug status in Europe. It was previously granted PRIME designation by the EMA.