FDA Accepts Tabelecleucel BLA; Priority Review Granted for Post-Transplant Disease Therapy

Atara Biotherapeutics announced today the FDA acceptance and priority review of the biologics license application (BLA) for tabelecleucel (tab-cel), according to a news release. A Prescription Drug User Fee Act (PDUFA) target action date has been set for January 10, 2026.

Tab-cel is indicated for adults and children at least two years of age with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy. The FDA has also granted tab-cel Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease, as well as orphan drug designation for EBV+ PTLD. There are currently no FDA-approved therapies for EBV+ PTLD. The monoclonal antibody Rituxan (rituximab) and chemotherapy are often used to treat the disease.

In January 2025, the FDA issued a complete response letter citing issues with a third-party manufacturing facility, but not the efficacy or safety of the drug.

“The acceptance of the tab-cel resubmission moves us one step closer towards making this first-of-its-kind treatment available to patients in the United States,” Cokey Nguyen, president and CEO of Atara, said in the news release. “We continue to work closely with the Pierre Fabre Pharmaceuticals team to help prepare for the potential launch in the United States.”

This BLA acceptance is supported by data from the Allele study, which has tested tab-cel in more than 430 patients. The latest results show that it demonstrated a 49% objective response rate in patients.

Post-transplant lymphoproliferative disease is a type of lymphoma that can develop after a solid organ or stem cell transplant. Seventy-five percent of cases are caused by the Epstein-Barr virus, which can be acquired from the donor or from environmental exposure. Reported incidence is between 2% and 20% of transplants.

Tab-cel is an allogenic T-cell immunotherapy therapy designed to eliminate EBV-infected cells.

Higher rates of EBV+ PTLD have been observed in patients receiving heart, lung, small bowel or combined heart-lung transplants, partly due to the need for higher doses of immunosuppression medications to prevent transplant rejection.

Last October, the Institute for Clinical and Economic Review said that tab-cel would be a cost-effective cell therapy to treat post-transplant complications if priced between $143,900 and $273,700 per treatment cycle.

Epstein-Barr virus, or human herpesvirus 4, is the most common cause of infectious mononucleosis, also called “mono,” according to the Centers for Disease Control and Prevention. It is one of the most common viruses in the world. In the United States, approximately 50% of all children up to age 5 and approximately 95% of adults have had it.

Epstein-Barr virus spreads primarily through body fluids such as saliva and is very contagious. Symptoms include fatigue, fever, inflamed lymph nodes, enlarged spleen, swollen liver, and rash. Once someone catches it, it remains latent in the body. In some cases, such as an organ transplant, the virus may reactivate.

Tab-cel is already available in Europe, marketed by Pierre Fabre under the brand name Ebvallo. Pierre Fabre is set to market tab-cel in the United States as well, based on a December 2023 agreement between Pierre Fabre and Atara.