Atara Biotherapeutics and Pierre Fabre request FDA Type A meeting post-CRL for EBVALLO (tabelecleucel) BLA, citing ALLELE study data for PTLD. Updated efficacy and EU insights aim for U.S. approval path
Written By: Pharmacally Medical News Desk
Atara Biotherapeutics, Inc. a pioneer in allogeneic T-cell immunotherapy targeting Epstein-Barr virus (EBV)-associated diseases, announced today that its partner Pierre Fabre Pharmaceuticals (PFP) has requested a Type A meeting with the U.S. Food and Drug Administration (FDA).
This pivotal step follows the FDA’s Complete Response Letter (CRL) issued on January 9, 2026, for the Biologics License Application (BLA) of tabelecleucel (tab-cel), an off-the-shelf EBV-specific T-cell therapy designed for patients with relapsed or refractory post-transplant lymphoproliferative disorder (PTLD).
PFP submitted a comprehensive briefing book to the FDA, directly addressing the CRL’s concerns. It argues that the Phase 3 ALLELE study served as an adequate, well-controlled trial sufficient to support tab-cel’s approval.
The package also features updated, longer-term efficacy data from ALLELE, supplementary evidence from the broader tab-cel development program, and real-world post-marketing insights from Europe data poised for inclusion in a potential BLA resubmission.
“We are eager to engage in a constructive discussion with the FDA to chart a clear path forward for tabelecleucel,” stated Cokey Nguyen, President and Chief Executive Officer of Atara Biotherapeutics. Nguyen highlighted the urgent advocacy from the PTLD community, including physicians and patient groups, who stress tab-cel’s potential to fill a critical gap in treating this ultra-rare, life-threatening condition.
PTLD affects immunocompromised transplant recipients, often driven by EBV reactivation, and currently lacks approved targeted therapies in the U.S. This Type A meeting, typically scheduled within 30 days for CRL follow-ups, could accelerate resolution and pave the way for tab-cel’s U.S. availability.
Tab-cel has already received approval in Europe as a third-line treatment for EBV+ PTLD, underscoring its established safety and efficacy profile.
Atara’s EBV T-cell platform continues to advance in oncology and autoimmune indications, positioning the company as a leader in off-the-shelf cell therapies.
References
Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel, 03 March 2026, Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel :: Atara Biotherapeutics (ATRA)
FDA Issues Complete Response Letter for Atara’s EBVALLO in EBV-Positive Post-Transplant Lymphoproliferative Disease, 12 January 2026, https://pharmacally.com/fda-issues-complete-response-letter-for-ataras-ebvallo-in-ebv-positive-post-transplant-lymphoproliferative-disease/
Pierre Fabre Pharmaceuticals Submits Type A Meeting Request to U.S. Food and Drug Administration (FDA) for Tabelecleucel Biologic License Application (BLA), 03 March 2026, https://www.pierrefabrepharmaceuticals.com/sites/default/files/press/20260303_PS_Final_Type%20A%20Submission_Statement_0.pdf