FDA Accepts Tab-Cel BLA Resubmission for EBV-Positive PTLD

The FDA has accepted a resubmitted biologics license application (BLA) for tabelecleucel (Ebvallo; tab-cel), an allogeneic T-cell immunotherapy being evaluated for adults and children aged 2 years and older with Epstein-Barr virus–positive (EBV+) post-transplant lymphoproliferative disease (PTLD) who have received at least 1 prior therapy.¹

With this acceptance, the application has a Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027. If approved, tab-cel would be the first FDA-authorized treatment specifically for this population.

The resubmission seeks approval of tab-cel as monotherapy for patients with EBV+ PTLD following solid organ transplantation (SOT) or hematopoietic cell transplantation (HCT). The accepted application includes updated efficacy and safety data from the pivotal phase 3 ALLELE study (NCT03394365), including additional patients and longer follow-up, as well as supplemental evidence from expanded access programs, a separate clinical study, and commercial experience in Europe.

"People diagnosed with relapsed or refractory EBV+ PTLD urgently need new treatment options as they have no approved FDA therapies, and after failure of initial treatment their survival is limited, measured in only weeks to months," Adriana Herrera, CEO of PFP, stated in a news release. "We look forward to a collaborative review process focused on the growing body of evidence supporting [tab-cel] approval including more patients and increased follow-up within our pivotal study and extensive supplemental data primarily from our ongoing early access programs and commercial experience in Europe."

Regulatory History and Updated Submission

The latest resubmission follows 2 previous complete response letters (CRLs) from the FDA. In January 2025, the agency issued a CRL identifying deficiencies related to an inspection of a third-party manufacturing facility. The company subsequently resubmitted the application in July 2025, and the FDA accepted it for priority review.

In January 2026, the FDA issued a second CRL, determining that the application could not be approved in its then-current form. The agency raised concerns about the adequacy and interpretability of the ALLELE study as support for accelerated approval.

The latest resubmission followed alignment with the FDA during an April 2026 type A meeting. The sponsor has incorporated additional clinical follow-up and supplemental data into the application in response to the regulatory discussions.

ALLELE Study Findings

ALLELE was a pivotal, single-arm, phase 3 study evaluating tab-cel in adults and children aged 2 years and older with relapsed or refractory EBV+ PTLD after SOT or HCT.² Eligible patients had disease progression following rituximab (Rituxan)-containing therapy or, for certain HCT recipients, were unable to receive rituximab.

In the data set supporting the original BLA, tab-cel demonstrated an objective response rate (ORR) of 48.8% (P <.0001). Subsequent analyses reported an overall ORR of 50.7% (95% CI, 38.9%-62.4%).³ Response rates were similar across transplant populations, reaching 51.0% (95% CI, 36.3%-65.6%) among patients who underwent SOT and 50.0% (95% CI, 29.9%-70.1%) among those who underwent HCT.⁴

The previously reported safety findings included no cases of cytokine release syndrome, infusion reactions, or graft-vs-host disease. However, serious treatment-emergent adverse events occurred in 61.2% of patients in the SOT cohort and 65.4% of patients in the HCT cohort.

REFERENCES

1. Pierre Fabre Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Tabelecleucel for the Treatment of Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative Disease. News release. Pierre Fabre Pharmaceuticals. October 14, 2026. Accessed October 15, 2026. https://tinyurl.com/vezz44vn

2. A phase 3 study of tabelecleucel for participants with Epstein–Barr virus–associated post-transplant lymphoproliferative disease after failure with rituximab or rituximab and chemotherapy (ALLELE). ClinicalTrials.gov. Updated September 2, 2026. Accessed October 15, 2026. https://www.clinicaltrials.gov/study/NCT03394365

3. 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. July 24, 2025. Accessed October 15, 2026. https://tinyurl.com/3m782yxb

4. Ghobadi A, Baiocchi R, Beitinjaneh AM, et al. Updated clinical results: a multicenter, open-label, phase 3 study of tabelecleucel for solid organ or allogeneic hematopoietic cell transplant recipients with Epstein–Barr virus-driven post-transplant lymphoproliferative disease after failure of rituximab or rituximab plus chemotherapy. Blood. 2024;144(suppl 1):70. doi:10.1182/blood-2024-198159