T-cell immunotherapy company Atara Biotherapeutics Inc (Nasdaq: ATRA) announced on Wednesday that the U.S. FDA has accepted its Biologics License Application (BLA) for tabelecleucel (tab-cel), a treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). The BLA has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of 15 January 2025.

If approved, tab-cel would be the first FDA-approved therapy for EBV+ PTLD. The acceptance of the BLA triggers a USD20m milestone payment from Pierre Fabre Laboratories, with an additional USD60m contingent upon FDA approval.

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA submission is backed by data from over 430 patients, including pivotal ALLELE study results showing a 48.8% Objective Response Rate (ORR) and a favorable safety profile.

The treatment has previously received Breakthrough Therapy Designation and orphan drug status from the FDA. Marketing authorization was granted under the brand name Ebvallo™ by the European Commission in December 2022, the UK Medicines and Healthcare Products Regulatory Agency in May 2023, and Swissmedic in May 2024.

Atara, headquartered in Southern California, leverages its T-cell immunotherapy platform to develop treatments for cancers and autoimmune diseases. The company is the first to receive regulatory approval for an allogeneic T-cell therapy.