Atara Biotherapeutics Receives FDA Approval for Tabelecleucel to Treat Epstein-Barr Virus-Positive Disease
Atara Biotherapeutics has reported that the FDA has accepted its Biologics License Application (BLA) for tabelecleucel (tab-cel®). This treatment is designed to be used alone for both adults and children aged two and older who have Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) and have undergone at least one prior treatment. For patients who have received solid organ transplants, prior treatment may include chemotherapy unless it is deemed necessary.
The acceptance of the tab-cel BLA represents a significant step towards making this novel treatment available to U.S. patients. The priority review underscores the critical need for effective treatments in the EBV+ PTLD patient population.
Tab-cel is an allogeneic immunotherapy that uses T-cells specifically designed to target and eliminate cells infected with Epstein-Barr virus (EBV). The BLA is supported by pivotal and additional data from over of 430 patients have been treated with tab-cel for a range of severe conditions.
Tab-cel has received Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease from the U.S. FDA, along with receiving orphan drug designation.
Tab-cel was granted marketing authorisation under the brand name Ebvallo™ by the European Commission. The marketing authorization was granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom.
Ebvallo is indicated as a monotherapy for adults and children aged two years and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. For patients with solid organ transplants, prior therapy may include chemotherapy unless unsuitable.
