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)

Rhea-AI Summary

Atara Biotherapeutics (NASDAQ: ATRA) announced that the FDA has accepted and granted Priority Review for tabelecleucel's Biologics License Application (BLA). Tabelecleucel is a groundbreaking treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), with a PDUFA date set for January 10, 2026.

The therapy, developed in collaboration with Pierre Fabre Pharmaceuticals (PFP), would be the first FDA-approved treatment for EBV+ PTLD patients who have failed prior therapy. The BLA submission includes data from over 430 patients, including the pivotal ALLELE study. Tabelecleucel has already received marketing authorization in Europe (EBVALLO™), the UK, and Switzerland.

Positive

• First potential FDA-approved therapy for EBV+ PTLD patients with no current treatment options
• FDA granted Priority Review status for the BLA application
• Therapy already approved in major markets (EU, UK, Switzerland)
• Robust clinical data from over 430 treated patients
• Strategic manufacturing and licensing partnership with Pierre Fabre strengthens commercial capabilities

Negative

• Previous Complete Response Letter from FDA in January 2025 due to manufacturing facility issues
• Complex manufacturing process requiring third-party facilities
• Ultra-rare disease indication may limit market size

Insights

Biotech Regulatory Analyst

FDA's priority review of tabelecleucel for a rare, deadly disease brings ATRA closer to potential first-in-class US approval.

The FDA's acceptance of tabelecleucel's BLA with Priority Review represents a significant regulatory milestone for Atara Biotherapeutics (ATRA) and its partner Pierre Fabre Pharmaceuticals. This regulatory designation is particularly meaningful as it's granted to therapies that, if approved, would provide significant improvements in the treatment of serious conditions. The January 10, 2026 PDUFA date now gives investors a clear timeline for this potential catalyst.

What makes this application particularly noteworthy is tabelecleucel's position as the first allogeneic T-cell therapy BLA for EBV+ PTLD, an ultra-rare blood cancer with no FDA-approved treatments and extremely poor survival outcomes. Allogeneic ("off-the-shelf") cell therapies represent a significant advancement over autologous approaches as they don't require individual manufacturing for each patient, potentially offering broader accessibility and reduced production costs.

The regulatory pathway appears to be strengthening after the companies addressed manufacturing facility observations from a previous Complete Response Letter in January 2025. This quick resolution (resubmission by July 11) suggests the issues were addressable and not related to the therapy's efficacy or safety profile. The BLA includes robust clinical data from over 430 patients, including the pivotal ALLELE study.

Importantly, tabelecleucel has already secured approvals in Europe (December 2022), the UK (May 2023), and Switzerland (May 2024), providing regulatory validation that strengthens the probability of FDA approval. The transition of manufacturing responsibilities to Pierre Fabre in March 2025 and the recent transfer of the Investigational New Drug Application signal significant progress in the commercialization strategy.

First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatment

EBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppression

Tabelecleucel has a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026 and would be the first approved therapy in the U.S. for EBV+ PTLD

SECAUCUS, N.J., July 24, 2025 /PRNewswire/ -- Pierre Fabre Pharmaceuticals Inc. (PFP) announces the acceptance by U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) and Priority Review of tabelecleucel, indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.

Atara Biotherapeutics Inc. (Nasdaq: ATRA) resubmitted the tabelecleucel BLA on July 11, having in collaboration with PFP, swiftly addressed the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter.

"Patients diagnosed with relapsed or refractory EBV+ PTLD have no approved FDA treatment options, and following failure of initial therapy their survival is unfortunately measured in only weeks to months. Today's BLA acceptance gives hope to these patients and is a significant step towards making this innovative cell therapy available in the United States," said Adriana Herrera, Chief Executive Officer of PFP, the Pierre Fabre Laboratories Pharmaceutical subsidiary in the U.S. "We are now completely focused on preparing for potential FDA approval of this innovative new treatment option."

Tabelecleucel is an allogeneic, off the shelf, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells. The BLA includes data covering more than 430 patients treated with tabelecleucel including the ongoing pivotal ALLELE study investigating the therapy in adults and children two years of age and older with relapsed or refractory EBV+ PTLD following SOT or HCT.

Tabelecleucel was granted marketing authorization under the brand name EBVALLO™ in December 2022 by the European Commission (EC). Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024.

Since March 31, 2025, PFP has assumed global responsibility for tabelecleucel manufacturing of commercial product for European markets and for global clinical trial supply. On July 15, 2025, Atara Biotherapeutics transferred the tabelecleucel Investigational New Drug Application to Pierre Fabre Medicament, a subsidiary of Pierre Fabre Laboratories. As per the terms of the restated exclusive worldwide licensing agreement between Atara and Pierre Fabre Laboratories announced in November 2023, Atara is responsible for regulatory procedures up until BLA transfer to Pierre Fabre Pharmaceuticals. 

About Pierre Fabre Pharmaceuticals and Pierre Fabre Laboratories
The mission of PFP is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better.

PFP is the US pharmaceutical subsidiary of Pierre Fabre Laboratories, a foundation-owned company with seven decades of impact. Pierre Fabre Laboratories is a global healthcare company, established in 43 countries, with over 10,000 employees, and with products distributed in 120 territories across the globe.
The Pierre Fabre Laboratories foundation ownership enhances the ability of the company to create long-term value for patients. Partnerships and acquisitions drive its innovative precision treatment pipeline and are enabled by the unique corporate structure.

Building on the legacy of Pierre Fabre Laboratories, innovation is the life blood of PFP, and patient experience drives everything the company does. PFP aspires to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action.

Pierre Fabre Pharmaceuticals has therapies in development for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), NRAS-mutant melanoma, non-small cell lung cancer with mutation or amplification of MET, and X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED). Pierre Fabre Pharmaceuticals is headquartered in Secaucus, NJ.

For more information, visit www.pierrefabrepharmaceuticals.com, www.pierre-fabre.com, @Pierre Fabre Oncology.

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SOURCE Pierre Fabre Pharmaceuticals

FAQ

When is the FDA PDUFA date for Atara's tabelecleucel (ATRA stock)?

The FDA has set a PDUFA target action date of January 10, 2026 for tabelecleucel.

What is tabelecleucel's treatment purpose for ATRA stock?

Tabelecleucel is an allogeneic T-cell therapy designed to treat EBV+ PTLD in patients who have received at least one prior therapy following solid organ or hematopoietic cell transplant.

How many patients were included in Atara's tabelecleucel BLA submission?

The BLA submission includes data from more than 430 patients treated with tabelecleucel, including the pivotal ALLELE study.

Where has Atara's tabelecleucel already received approval?

Tabelecleucel (EBVALLO™) has received marketing authorization in the European Union (December 2022), United Kingdom (May 2023), and Switzerland (May 2024).

What is the current survival rate for EBV+ PTLD patients without treatment?

According to the press release, patients with relapsed or refractory EBV+ PTLD have survival rates measured in only weeks to months following failure of initial therapy.