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EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.
On Nov. 30, 2021, Atara Biotherapeutics announced that the European Medicines Agency (EMA) has fully validated the company’s marketing authorization application (MAA) for tab-cel (tabelecleucel), an investigational off-the-shelf allogeneic T-cell immunotherapy being developed to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EMA is expected to announce a decision on approval for the MAA in the second half of 2022 based on an evaluation by the Committee for Medicinal Products for Human Use (CHMP).
The MAA is seeking approval for treatment of patients with EBV+ PTLD who have received at least one prior therapy following solid organ transplant (SOT) or hematopoietic cell transplant (HCT).
Tab-cel is Atara’s lead candidate for EBV-positive cancers, including EBV+ PTLD. It is currently being investigated in adults and children in an ongoing Phase III trial. The MAA includes positive data from the study, which demonstrates a 50% objective response rate (ORR), as measured by an independent oncologic response adjudication (IORA) assessment. The study has thus far demonstrated an ORR of 50% in PTLD following SOT and an ORR of 50% in PTLD following HCT, with a best overall response of complete response or partial response.
Atara will present its findings from the Phase III study and additional tab-cel data in eight abstracts at the 63rd American Society of Hematology Annual Meeting being held on December 11–14, 2021 in Atlanta, GA.
Tab-cel was granted breakthrough therapy designation for EBV+ PTLD following allogeneic HCT by FDA and priority medicines designation by the EMA for the same indication. Tab-cel has orphan drug designation in both the United States and European Union (EU).
In October 2021, Atara entered into an exclusive commercialization agreement with Pierre Fabre for tab-cel in Europe, Middle East, Africa and other select emerging markets for EBV-positive cancers. Under the agreement, Atara is responsible for the Phase III study currently underway in PTLD and is responsible for submitting the EU MAA. The company also remains responsible for a Phase II multi-cohort study, in which tab-cel is being evaluated in six additional patient populations. The goal of the Phase II study is 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.
“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 vice-president and global head of Research and Development at Atara, in a company press release. “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.”
Source: Atara Biotherapeutics