FDA accepts Atara Biotherapeutics’ Tab-Cel for priority review
Betsy Goodfellow | July 18, 2024 | News story | Medical Communications | Atara Biotherapeutics, FDA, Virology, priority review
Atara Biotherapeutics has announced that the US Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel) as a monotherapy for the treatment of adult and paediatric patients over the age of two 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 with a Prescription Drug User Fee Act (PDUFA) target action data of 15 January 2025.
According to the press release, ‘tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells’.
The BLA is supported by data covering over 430 patients treated with the drug across various indications, including data from the recent ALLELE study which demonstrated an Overall Response Rate (ORR) of 48.8% as well as a positive safety profile.
Pascal Touchon, president and chief executive officer of Atara, commented: “The acceptance of the tab-cel BLA is a significant milestone towards making this first-of-its-kind treatment available to patients in the US. The FDA’s granting of priority review highlights the high unmet need in EBV + PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate. We continue to work closely with the Pierre Fabre Laboratories team to help prepare for the potential launch in the US in early 2025, along with the potential label expansion multicohort phase 2 EBVision trial.”
Betsy Goodfellow
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