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.

FDA Accepted - October 14,2026

BLA

• Drug: Tabelecleucel (tab-cel)
• Announced Date: October 14, 2026
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc. announced that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has received acceptance by the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) resubmission for tabelecleucel, with a proposed indication 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.

FDA Meeting Request - March 3,2026

Type A Meeting

• Drug: Tabelecleucel (tab-cel)
• Announced Date: March 3, 2026
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc announced that its partner Pierre Fabre Pharmaceuticals (PFP) has submitted a request to the FDA for a Type A meeting.

Atara Biotherapeutics said its partner, Pierre Fabre Pharmaceuticals (PFP), has formally asked the U.S. Food and Drug Administration for a Type A meeting. The companies are pursuing regulatory guidance and next steps for their joint program, and Atara reported the request to keep investors and the public informed.

Type A meetings are used when companies need prompt FDA attention on time-sensitive or urgent matters, such as resolving critical questions that could affect development or approval plans. A favorable or clear outcome could help shape the program’s timeline and regulatory strategy. Atara said it will provide updates after the FDA responds and the meeting is scheduled or held.

Provided Update - January 12,2026

• Drug: Tabelecleucel (tab-cel)
• Announced Date: January 12, 2026
• Indication: Post-Transplant Lymphoproliferative Disease (PTLD)

Atara Biotherapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the EBVALLO™ (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 announced that the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for its EBVALLO™ (tabelecleucel) Biologics License Application (BLA). EBVALLO is proposed 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 received at least one prior therapy, including an anti‑CD20–containing regimen.

A CRL means the FDA will not approve the BLA in its current form and has identified issues that must be resolved before approval can be granted. Atara said it is reviewing the CRL, will engage with the FDA to determine required actions, and will evaluate next steps to address the agency’s concerns. The company affirmed its commitment to advancing EBVALLO for patients with EBV+ PTLD, a rare and serious condition with limited treatment options.

PDUFA Date - July 24,2025

BLA

• Drug: Tabelecleucel (tab-cel)
• Announced Date: July 24, 2025
• 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.