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European Medicines Agency (EMA) Validates Atara Biotherapeutics' Marketing Authorization Application for Tabelecleucel for the Treatment of Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease
First-Ever Off-The-Shelf Allogeneic T-Cell Therapy to be Reviewed by any Regulatory Agency in the World EMA Priority Medicines (PRIME) and Orphan Designated
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nFirst-Ever Off-The-Shelf Allogeneic T-Cell Therapy to be Reviewed by any Regulatory Agency in the World\n\nEMA Priority Medicines (PRIME) and Orphan Designated Tabelecleucel One Step Closer for Patients with High Unmet Need\n\nEU Approval Decision Anticipated for Second Half of 2022, based on CHMP Accelerated Assessment\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that the Marketing Authorization Application (MAA) for tabelecleucel (tab-cel®) has been fully validated by the European Medicines Agency (EMA). 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).\n\nThe 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 in the European Economic Area countries Iceland, Liechtenstein, and Norway.\n\n“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, MD, Executive Vice President and Global Head of Research and Development at Atara. “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.”\n\nTab-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 includes positive data from this study, which demonstrates a 50% (19/38, 95% CI: 33.4, 66.6) objective response rate (ORR) as measured by independent oncologic response adjudication (IORA) assessment, with an ORR of 50% (12/24, 95% CI: 29.1, 70.9) in PTLD following SOT and 50% (7/14, CI: 23.0, 77...