FDA Policy/General

Atara says FDA outlined potential path for Cell Therapy Resubmission

Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting their BLA for tabelecleucel, an investigational T-cell therapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). The companies recently held a Type A meeting with the agency to discuss a recent complete response letter.

According to Atara, the FDA agreed that a single-arm study using an appropriate historical control, if conducted in a prespecified manner, could serve as an “adequate and well-controlled” study capable of supporting a future marketing application for the therapy.

Pierre Fabre plans to submit updated data from the pivotal Phase 3 ALLELE study, including additional patients and longer follow-up, as part of a resubmission package currently being defined with FDA, the company says.

The application covers adults and children aged two and older with relapsed or refractory EBV+ PTLD following solid organ transplant or hematopoietic cell transplant.

Tab-cel is an allogeneic Epstein-Barr virus-specific T-cell immunotherapy developed on Atara’s off-the-shelf cell therapy platform. The company has positioned the therapy as a potential treatment option for patients with limited alternatives after transplant-related complications.

In January, FDA issued the companies a second complete response letter on the BLA, citing the need for additional clinical evidence. That application had been resubmitted after what the companies described as alignment with FDA on the criteria for resubmission following an earlier complete response letter issued 1/2025, which identified a single good manufacturing practice deficiency and raised no concerns about safety, efficacy, or trial design, according to the companies.

Atara describes tab-cel as an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by data from more than 430 patients treated with tab-cel across multiple life-threatening diseases, including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% objective response rate and favorable safety profile consistent with previous analyses, it says.

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