FDA Accepts Resubmitted Tabelecleucel BLA for EBV-Positive PTLD

The FDA has accepted a resubmitted biologics license application (BLA) for tabelecleucel (tab-cel; Ebvallo), with a proposed indication as monotherapy for adult and pediatric patients who are 2 years and older with Epstein-Barr virus (EBV)–positive post-transplant lymphoproliferative disease (PTLD) and have received at least 1 prior therapy, according to a news release from the developer, Atara Biotherapeutics.¹

The BLA, which was resubmitted by Atara’s partner, Pierre Fabre Pharmaceuticals (PFP), has a Class 2 resubmission Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027. If approved, tab-cel would be the first therapy available in the US for EBV-positive PTLD.

What does the tabelecleucel BLA acceptance entail?

PFP, which holds the application, received the FDA’s acceptance of the BLA resubmission for tab-cel. Previously, tab-cel received breakthrough therapy designation for the treatment of rituximab (Rituxan)-refractory EBV-associated lymphoproliferative disease and orphan drug designation for the treatment of EBV-positive PTLD.

“The acceptance of the [tab-cel] resubmission brings us one step closer to making this first-of-its-kind treatment available to patients in the US,” said Cokey Nguyen, PhD, president and chief executive officer at Atara, in the news release.¹ “We appreciate the Agency’s guidance and look forward to a collaborative review process. We will continue supporting PFP as it prepares for a potential US launch.”

What is the regulatory history of tabelecleucel in the US?

The acceptance follows the resubmission of the BLA for tab-cel by PFP in September 2026, with Atara’s support, based on feedback from a Type A meeting with the FDA held in April 2026.² That resubmission included an updated data package with additional patients and longer follow-up from the ongoing pivotal phase 3 ALLELE study (NCT03394365), as well as supplemental data from the expanded access programs, a separate clinical study, and commercial experience in Europe.

The resubmission followed a complete response letter (CRL) that the FDA issued in January 2026, in which the agency stated that findings from the ALLELE trial were no longer sufficient to support accelerated approval because the study’s design, conduct, and analysis confounded its interpretability; the agency identified no safety issues and noted that developers had satisfactorily resolved the Good Manufacturing Practices issues cited in a prior letter.³ That action followed an earlier CRL in January 2025 related primarily to observations at a third-party manufacturing facility, a subsequent clinical hold on the investigational new drug application that was lifted in May 2025, and an FDA acceptance and priority review of a resubmitted BLA in July 2025.^4-6

What did the ALLELE trial show?

In the international, open-label, multicenter phase 3 ALLELE trial, patients received tab-cel at 2.0 × 10⁶ cells/kg intravenously on days 1, 8, and 15 of each approximately 5-week cycle, with a primary end point of overall response rate (ORR).⁷ Among all patients (n = 75), the ORR was 50.7% (95% CI, 38.9%-62.4%), including complete responses in 28.0% and partial responses in 22.7%. The ORR was 50.0% among 26 patients with prior hematopoietic cell transplant (HCT) and 51.0% among 49 patients with prior solid organ transplant (SOT).

At 12 months, the overall survival (OS) rate was 55.7% among all patients, 78.7% in those with a response, and 28.2% in those without a response. The median OS was 18.4 months (95% CI, 5.7-not evaluable [NE]) overall, NE (95% CI, 18.6 months-NE) in responders, and 3.7 months (95% CI, 1.8-11.0) in nonresponders.

Treatment-emergent serious adverse effects occurred in 62.7% of patients, which included 8.0% that were related to treatment, with no instances of tumor flare reactions, infusion-related reactions, cytokine release syndrome, or immune effector cell–associated neurotoxicity syndrome reported.

References

1. Atara Biotherapeutics reports that the resubmitted tabelecleucel (tab-cel) biologics license application has been accepted by the US Food and Drug Administration. News release. Atara Biotherapeutics, Inc. October 14, 2026. Accessed October 14, 2026. https://tinyurl.com/2bdx22me
2. Atara Biotherapeutics reports that the tabelecleucel biologics license application has been resubmitted to the US Food and Drug Administration. News release. Atara Biotherapeutics, Inc. September 30, 2026. Accessed October 14, 2026. https://tinyurl.com/44cttxj9
3. Atara Biotherapeutics provides regulatory and business update on EBVALLO (tabelecleucel). News release. Atara Biotherapeutics. January 12, 2026. Accessed October 14, 2026. https://tinyurl.com/5h34yxtx
4. Atara Biotherapeutics provides regulatory and business update on EBVALLO (tabelecleucel). News release. Atara Biotherapeutics. January 16, 2025. Accessed October 14, 2026. https://tinyurl.com/3p9jrrtj
5. Atara Biotherapeutics provides regulatory updates on EBVALLO (tabelecleucel). News release. Atara Biotherapeutics. May 5, 2025. Accessed October 14, 2026. https://tinyurl.com/3cekvud5
6. Pierre Fabre Pharmaceuticals Inc. announces FDA acceptance and priority review of the biologics license application (BLA) for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). News release. Pierre Fabre Pharmaceuticals. July 25, 2025. Accessed October 14, 2026. https://tinyurl.com/5hfdh7cn
7. Dierick D, Ghobadi A, Baiocchi R, et al. Updated results: multicenter open-label ph 3 study of tabelecleucel for SOT or HCT recipients with EBV+ PTLD after failure of rituximab or rituximab + chemotherapy. Presented at: 51st Annual Meeting of the European Society for Blood and Marrow Transplantation; March 30-April 2, 2025; Florence, Italy. Abstract OS17-03.