FDA Accepts Atara Biotherapeutics’ Resubmission of BLA for Tabelecleucel
Notably, the BLA resubmission was accepted with priority review and the PDUFA target action date has been set for January 10, 2026.
Cokey Nguyen, PhD
(Image credit: Atara)
The FDA has accepted Atara Biotherapeutics' resubmission of a biologics license application (BLA) for allogeneic Epstein-Barr virus (EBV)–specific T-cell immunotherapy tabelecleucel (tab-cel; Ebvallo), which is intended to treat patients 2 years or older with EBV-positive posttransplant lymphoproliferative disease (EBV+ PTLD) who have received at least 1 prior therapy.1
Notably, the BLA resubmission was accepted with priority review and the Prescription Drug User Fee Act (PDUFA) target action date has been set for January 10, 2026. Atara pointed out that as of now there are no therapies approved by the FDA for the aforementioned treatment setting.
“The acceptance of the tab-cel resubmission moves us 1 step closer towards making this first-of-its-kind treatment available to patients in the United States,” Cokey Nguyen, PhD, the president and chief executive officer of Atara, said in a statement.1 “We continue to work closely with the Pierre Fabre Pharmaceuticals team to help prepare for the potential launch in the US.”
Atara previously submitted a BLA for tab-cel to the FDA in May 2024, but was met with a complete response letter (CRL) in January 2025.2,3 The CRL was related to issues with a standard prelicense inspection of a third-party manufacturer for tab-cel rather than to any concerns regarding the efficacy and safety data contained within the BLA. The manufacturing process itself was not implicated, and the FDA did not request additional clinical trials for tab-cel.
“We are working closely with our partner Pierre Fabre Laboratories, the FDA, and the third-party manufacturer to address the feedback to support marketing approval for Ebvallo,” Nguyen said in a January 2025 statement.1 “Once the third-party manufacturer good manufacturing practice (GMP) compliance issues have been adequately addressed, we will file for a resubmission.... Atara and its partner Pierre Fabre remain confident in the potential of Ebvallo and are committed to bringing this potential first-in-class medicine to United States patients with EBV+ PTLD who have limited treatment options and significant unmet need.”
The BLA is supported by data from the pivotal phase 3 ALLELE clinical trial (NCT03394365) and other studies that cumulatively include greater than 430 patients with multiple diseases. Notably, a 48.8% objective response rate was observed in ALLELE (P < .0001) in the most up-to-date data, and according to Atara, the safety profile of tab-cel in the trial was favorable and in line with earlier analyses.
Tab-cel is approved in the European Union, the United Kingdom, and Switzerland for the treatment of relapsed/refractory EBV+ PTLD in patients aged 2 years and older who have received at least 1 prior therapy.2 In January 2025, Atara stated that a manufacturing facility located in Thousand Oaks, California, operated by FUJIFILM Diosynth Biotechnologies, a separate third-party manufacturer from the one identified in the aforementioned CRL, had recently gained approval from the European Medicines Agency to manufacture tab-cel.3 Tab-cel has previously received FDA breakthrough therapy designation for rituximab-refractory EBV-associated lymphoproliferative disease and FDA orphan drug designation for EBV-positive post-transplant lymphoproliferative disorders.
Atara is not the only company targeting EBV-associated conditions with cell therapy.4 Biosyngen is currently developing chimeric antigen receptor T-cell therapy BRG01 for EBV-positive relapsed/metastatic nasopharyngeal carcinoma. In August 2024, BRG01 was cleared by the FDA for a pivotal phase 2 clinical trial in that indication, a decision that was preceded by the Center for Drug Evaluation of China’s National Medical Products Administration move in July 2024 to clear the company for a phase 2 pivotal clinical trial for BRG01 in China.5
REFERENCES
1. Atara Biotherapeutics announces U.S. FDA acceptance and priority review of the biologics license application for tabelecleucel (tab-cel®) for the treatment of epstein-barr virus positive post-transplant lymphoproliferative disease. News release. Atara Biotherapeutics, Inc. July 24, 2025. Accessed July 31, 2025. https://investors.atarabio.com/news-events/press-releases/detail/376/atara-biotherapeutics-announces-u-s-fda-acceptance-and
2. Atara Biotherapeutics Submits Tabelecleucel (Tab-cel) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA. News release. Atara Biotherapeutics. May 20, 2024. Accessed July 31, 2025. https://www.businesswire.com/news/home/20240520985176/en/Atara-Biotherapeutics-Submits-Tabelecleucel-Tab-cel%C2%AE-Biologics-License-Application-for-Treatment-of-Epstein-Barr-Virus-Positive-Post-Transplant-Lymphoproliferative-Disease-with-U.S.-FDA
3. Atara Biotherapeutics provides regulatory and business update on EBVALLO (tabelecleucel). News release. Atara Biotherapeutics Inc. January 16, 2025. Accessed July 31, 2025. https://investors.atarabio.com/news-events/press-releases/detail/367/atara-biotherapeutics-provides-regulatory-and-business
4. Biosyngen’s BRG01 receives FDA approval for phase II clinical trial. News release. Biosyngen. August 12, 2024. Accessed July 31, 2025. https://www.biosyngen.com/index.php/Classification/38.html
5. Biosyngen’s BRG01 enters phase II clinical trial, A first-in-kind autologous EBV-specific CAR-T therapy for solid tumors on recurrent/metastatic nasopharyngeal carcinoma. News release. Biosyngen. July 16, 2024. Accessed July 31, 2025. https://firstwordpharma.com/story/5876299
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