FDA Events for Atara Biotherapeutics (ATRA)
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.
- Drug:
- Tabelecleucel (tab-cel)
- Announced Date:
- January 21, 2025
- Indication:
- Post-Transplant Lymphoproliferative Disease (PTLD)
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- Tabelecleucel (tab-cel)
- Announced Date:
- January 16, 2025
- Indication:
- Post-Transplant Lymphoproliferative Disease (PTLD)
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- Tabelecleucel (tab-cel)
- Announced Date:
- July 17, 2024
- Indication:
- Post-Transplant Lymphoproliferative Disease (PTLD)
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- Tabelecleucel (tab-cel)
- Announced Date:
- July 17, 2024
- Indication:
- Post-Transplant Lymphoproliferative Disease (PTLD)
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- Tabelecleucel (tab-cel)
- Announced Date:
- May 20, 2024
- Indication:
- Post-Transplant Lymphoproliferative Disease (PTLD)
Announcement
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.
AI Summary
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.
Read Announcement
Atara Biotherapeutics FDA Events - Frequently Asked Questions
As of now, Atara Biotherapeutics (ATRA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Atara Biotherapeutics (ATRA) has reported FDA regulatory activity for Tabelecleucel (tab-cel).
The most recent FDA-related event for Atara Biotherapeutics occurred on January 21, 2025, involving Tabelecleucel (tab-cel). The update was categorized as "Clinical Hold," with the company reporting: "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."
Currently, Atara Biotherapeutics has one therapy (Tabelecleucel (tab-cel)) targeting the following condition: Post-Transplant Lymphoproliferative Disease (PTLD).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ATRA) was last updated on 7/12/2025 by MarketBeat.com Staff
