EMA to review Atara's MAA submission for allogeneic T-cell therapy: ‘A watershed moment for the field’

30-Nov-2021 - Last updated on 30-Nov-2021 at 16:08 GMT

The EMA has validated Atara Biotherapeutics' Marketing Authorization Application (MAA) for tabelecleucel (tab-cel), the first time an off-the-shelf allogeneic T-cell therapy will be evaluated by any regulatory agency in the world.

Tab-cel is an investigational treatment for patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy following solid organ transplant (SOT) or hematopoietic cell transplant (HCT).

“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,” said Jakob Dupont, executive VP and global head of research and development, at the San Francisco headquartered Atara.

This is “a watershed moment for the field,” he added.

Atara’s application will be evaluated by the EMA’s Committee for Medicinal Products for Human Use (CHMP) under the centralized licensing procedure for all EU member states, as well as EEA markets.

The EMA already granted tab-cel Priority Medicines (PRIME) and orphan drug designation for the treatment of EBV+ PTLD, a type of lymphoma that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT).

Tab-cel has also been given Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the US Food and Drug Administration (FDA). It has orphan drug designation in the US as well.

The MAA submission includes findings from Atara’s ongoing Phase 3, registration-enabling ALLELE study; those results will also be presented at the upcoming 63rd American Society of Hematology (ASH) Annual Meeting taking place December 11-14, 2021.

Teaming up with Pierre Fabre

In October 2021, Atara entered into an exclusive commercialization agreement with French pharma group, Pierre Fabre, for tab-cel in the EMEA region and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers.

In addition to responsibility for the pivotal ALLELE study in PTLD and submitting the EU MAA, Atara said it also remains responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel in six additional patient populations with the goal of label expansion in other EBV-driven cancers.

Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe.