Atara Biotherapeutics and Pierre Fabre outlined a potential regulatory path for resubmitting the BLA for tabelecleucel after a Type A meeting with the FDA. The agency indicated that updated Phase 3 ALLELE study data, supported by a pre-specified historical control analysis, could support a future marketing application in relapsed or refractory EBV+ PTLD following transplant.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Atara Biotherapeutics and partner Pierre Fabre Pharmaceuticals have outlined a potential regulatory path forward for the biologics license application (BLA) of tabelecleucel (tab-cel) following a recent Type A meeting with the U.S. Food and Drug Administration (FDA).
The meeting was held to discuss the Complete Response Letter (CRL) issued for the BLA seeking approval of tab-cel for adults and children aged two years and older with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (R/R EBV+ PTLD) following solid organ transplant or hematopoietic cell transplant.
The FDA accepted the tab-cel BLA for review in July 2025. Pierre Fabre assumed control of the application following its transfer from Atara in November 2025. The FDA later issued a CRL on January 9, 2026.
According to Atara, the FDA agreed that a single-arm study using an appropriate historical control, applied in a pre-specified manner, could serve as an adequate and well-controlled study to support a future marketing application for tab-cel. The agency also indicated that such an approach could provide sufficient safety and efficacy data for the proposed indication.
Pierre Fabre plans to include updated clinical data from the pivotal Phase 3 ALLELE study as part of the resubmission strategy currently being defined with the FDA. The updated package is expected to contain additional patient data and longer follow-up from the single-arm trial, along with supportive evidence.
The ALLELE study evaluated tab-cel in patients with R/R EBV+ PTLD, a rare and potentially life-threatening complication that can develop after organ or stem cell transplantation due to immunosuppression and uncontrolled Epstein-Barr virus infection.
“We are grateful to the agency for engaging in a collaborative conversation with our partners, Pierre Fabre, and us. We appreciate the FDA’s continued engagement with PFP and Atara, and we believe the Type A Meeting provided helpful alignment on the regulatory framework to resubmit,” said President and CEO of Atara, Cokey Nguyen.
Nguyen added that Atara will continue supporting Pierre Fabre in preparing the resubmission and expects to provide another regulatory update in the third quarter.
Tab-cel is an allogeneic Epstein-Barr virus-specific T-cell immunotherapy designed to target EBV-infected cells. The therapy is being developed using Atara’s off-the-shelf T-cell platform for cancer and autoimmune diseases.
Reference
Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel :: Atara Biotherapeutics (ATRA)
About the Writer
Nikita Jha, BPharm (LinkedIn) a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.