Cell Therapy
Regulatory & Standards

EMA to Review First Ever Off-The-Shelf Allogeneic T-Cell Therapy from Atara Bio

Georgi Makin
1 December 2021
Atara Bio has announced that the EMA has fully validated the Marketing Authorisation Application (MAA) for tabelecleucel (tab-cel®), and is the first regulatory agency in the world to review an off-the-shelf allogeneic T-cell therapy.

Tab-cel has been described as an investigational treatment for patients with Epstein-Barr virus-positive post-transplant lymphoproliferative following at least one prior therapy following solid organ transplant or hematopoietic cell transplant.

As Jakob Dupont, Executive Vice President and Global Head of Research and Development at Atara explained:

“Tab-cel is the first-ever off-the-shelf allogeneic T-cell therapy to be reviewed by a regulatory agency and is a watershed moment for the field and for patients with significant unmet need. We look forward to working with the EMA as the agency evaluates the transformative potential of tab-cel. EBV+ PTLD is a rare and aggressive cancer where the patients we seek to treat only have weeks to a few months’ survival after treatment failure, with no approved options”

Atara Bio is anticipating hearing about an EU approval decision in the second half of 2022, following evaluation by the EMA’s Committee for Medicinal Products for Human Use (CHMP) under the centralised licensing procedure for all EU Member States, as well as in the European Economic Area countries Iceland, Liechtenstein and Norway.

According to a recent press release, tab-cel is Atara’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is being investigated in adults and children in the ongoing Phase 3, registration-enabling ALLELE study.

The MAA reportedly includes positive data from the ALLELE study, which suggested that those who responded to tab-cel had a longer survival rate compared to the non-responders. The study reported responders to have a one-year survival rate of 89.2%, compared with 32.4% in non-responders.

A press release further reported that no new signals were reported as safety findings, with no reports of tumour flare reaction as well as no confirmed evidence of graft versus host disease (GvHD), organ rejection, infusion reactions, or cytokine release syndrome (CRS) related to tab-cel.

Atara Bio recently announced an exclusive commercialisation agreement with Pierre Fabre for tab-cel in Europe, Middle East, Africa and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers.

As part of this agreement, Atara Bio is responsible for the ALLELE study in PTLD, submitting the EU MAA, and conducting the Phase 2 multi-cohort study evaluating tab-cel in six additional patient populations with the goal of label expansion in other EBV-driven cancers. Pierre Fabre is then responsible for all commercialisation and distribution activities in the agreed territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe in late 2022.

Source: Atara Bio press release