Atara Biotherapeutics (ATRA) FDA Approvals

Atara Biotherapeutics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Atara Biotherapeutics (ATRA). Over the past two years, Atara Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Tabelecleucel. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Tabelecleucel (tab-cel) FDA Regulatory Timeline and Events

Tabelecleucel (tab-cel) is a drug developed by Atara Biotherapeutics for the following indication: Post-Transplant Lymphoproliferative Disease (PTLD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

PDUFA Date - July 24,2025

BLA

• Drug: Tabelecleucel (tab-cel)
• Announced Date: July 24, 2025
• Estimated Event Date Range: January 10, 2026 - January 10, 2026
• Target Action Date: January 10, 2026
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc announced that Prescription Drug User Fee Act (PDUFA) Target Action Date of January 10, 2026

Atara Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted its Biologics License Application (BLA) for tabelecleucel (tab-cel) as a monotherapy for adults and children aged two years and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. The BLA has been granted Priority Review and carries a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026.

Tab-cel is an off-the-shelf, allogeneic T-cell immunotherapy designed to identify and eliminate EBV-infected cells in life-threatening conditions. The submission is backed by data from more than 430 patients, including a pivotal study reporting a 48.8% objective response rate and a favorable safety profile. Atara is collaborating with Pierre Fabre Pharmaceuticals to prepare for a potential U.S. launch if the therapy is approved.

FDA Accepted - July 24,2025

BLA

• Drug: Tabelecleucel (tab-cel)
• Announced Date: July 24, 2025
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel®) 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, a T-cell immunotherapy company, announced that the FDA accepted its Biologics License Application for tabelecleucel (tab-cel®). The application seeks approval to use tab-cel as a monotherapy in adults and children aged two and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior treatment.

The FDA granted Priority Review and set a PDUFA target action date of January 10, 2026. If approved, tab-cel would become the first U.S. therapy specifically for EBV+ PTLD. The BLA is supported by data from over 430 patients, including pivotal ALLELE study results showing a 48.8% objective response rate and a favorable safety profile.

Tab-cel is an off-the-shelf, allogeneic T-cell therapy designed to identify and destroy EBV-infected cells. The treatment holds Breakthrough Therapy and orphan drug designations, highlighting its potential to address a critical unmet need in transplant patients.

Clinical Hold - January 21,2025

IND

• Drug: Tabelecleucel (tab-cel)
• Announced Date: January 21, 2025
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Atara's active Investigational New Drug (IND) applications.

Atara Biotherapeutics, Inc. announced that the FDA has placed a clinical hold on its active Investigational New Drug (IND) applications for EBVALLO (tabelecleucel) and ATA3219 studies. The clinical hold affects the EBVALLO program, which treats adult and pediatric patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, a CD19-targeted CAR-T therapy for non-Hodgkin’s lymphoma and systemic lupus erythematosus.

This decision comes after the FDA identified GMP compliance issues during an inspection of a third-party manufacturing facility mentioned in a Complete Response Letter. The hold means that while patients already enrolled and likely to benefit may continue receiving treatment under current protocols, the enrollment of new patients has been paused. Atara is now working closely with the FDA to resolve these issues so that the clinical holds can be lifted as soon as possible.

Complete Response Letter - January 16,2025

• Drug: Tabelecleucel (tab-cel)
• Announced Date: January 16, 2025
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the EBVALLOTM (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for 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 including an anti-CD20 containing regimen.

Atara Biotherapeutics recently received a Complete Response Letter (CRL) from the FDA regarding its EBVALLO Biologics License Application (BLA). The CRL is for use of EBVALLO as a monotherapy to treat adult and pediatric patients two years and older who have Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) and who have already received at least one prior therapy, including an anti-CD20 regimen. The FDA’s feedback was solely based on observations made during a routine inspection of a third-party manufacturing facility. It did not find any issues with the clinical efficacy or safety data, nor did it require any new clinical studies. Atara is working closely with the FDA, Pierre Fabre Laboratories, and the manufacturer to address these observations. The company is hopeful that once the manufacturing issues are resolved, the resubmitted application may be approved within six months.

FDA Accepted - July 17,2024

BLA

• Drug: Tabelecleucel (tab-cel)
• Announced Date: July 17, 2024
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel®) 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 recently announced that the U.S. FDA has accepted its Biologics License Application (BLA) for tabelecleucel (tab-cel®). The treatment is intended as a monotherapy for both adult and pediatric patients aged two years and older diagnosed with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have already received at least one therapy. This acceptance marks a significant milestone for Atara because there are currently no FDA-approved treatments for this condition. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date set for January 15, 2025. The FDA’s acceptance of the BLA underscores the urgent need for new treatment options in this area, potentially paving the way for a first-of-its-kind therapy that could make a meaningful difference for patients facing this severe disease.

PDUFA Date - July 17,2024

BLA

• Drug: Tabelecleucel (tab-cel)
• Announced Date: July 17, 2024
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc announced that The BLA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025.

Atara Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for tab-cel®, a novel T-cell immunotherapy targeting Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). The FDA has granted Priority Review to the application, with a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025. This decision highlights the critical need for effective treatments for EBV+ PTLD, a serious condition that currently has no approved therapy in the U.S.

If approved, tab-cel would be the first treatment option available for both adult and pediatric patients who have undergone at least one prior therapy. This milestone represents significant progress in addressing an unmet medical need and has raised hopes for improving outcomes for patients battling this challenging disease.

IND Filing - May 20,2024

BLA

• Drug: Tabelecleucel (tab-cel)
• Announced Date: May 20, 2024
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc announced that Atara has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (tab-cel®) 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 has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its immunotherapy, tabelecleucel (tab-cel®). The therapy is designed as a monotherapy for adult and pediatric patients aged two years and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have previously received at least one therapy. This submission targets a patient population that currently has no FDA-approved treatment options, making tab-cel a potentially groundbreaking solution. The application represents an important step forward for Atara as it seeks to bring the first allogeneic T-cell therapy to market in the U.S. for EBV+ PTLD. If approved, this move will also trigger significant milestone payments from their partner, Pierre Fabre Laboratories, further highlighting the therapy’s potential impact on patients in need.

Atara Biotherapeutics FDA Events - Frequently Asked Questions

Has Atara Biotherapeutics received FDA approval?

As of now, Atara Biotherapeutics (ATRA) has not received any FDA approvals for its therapy in the last two years.

What drugs has Atara Biotherapeutics submitted to the FDA?

In the past two years, Atara Biotherapeutics (ATRA) has reported FDA regulatory activity for Tabelecleucel (tab-cel).

What is the most recent FDA event for Atara Biotherapeutics?

The most recent FDA-related event for Atara Biotherapeutics occurred on July 24, 2025, involving Tabelecleucel (tab-cel). The update was categorized as "PDUFA Date," with the company reporting: "Atara Biotherapeutics, Inc announced that Prescription Drug User Fee Act (PDUFA) Target Action Date of January 10, 2026"

What conditions do Atara Biotherapeutics' current drugs treat?

Currently, Atara Biotherapeutics has one therapy (Tabelecleucel (tab-cel)) targeting the following condition: Post-Transplant Lymphoproliferative Disease (PTLD).