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Atara Biotherapeutics Seeking US Approval for EBV-Targeted T-Cell Therapy

NEW YORK – Atara Biotherapeutics on Monday said it submitted a biologics license application to the US Food and Drug Administration seeking approval for the T-cell immunotherapy tabelecleucel (tab-cel) as a second-line option for patients with Epstein-Barr virus-positive, post-transplant lymphoproliferative disease.

There are currently no FDA-approved therapies for EBV-positive, post-transplant lymphoproliferative disease, a disorder in which EBV-infected lymphoid cells divide excessively and can lead to precancer or cancer. Tab-cel is an allogeneic T-cell therapy designed to specifically target and eliminate EBV-infected cells.

Atara's application contains results from the ongoing pivotal Phase II ALLELE trial in which about 190 patients are receiving tab-cel intravenously for three weeks at a time, followed by two weeks of observation. Investigators are tracking patients' objective response rate, overall survival, duration of response, and progression-free survival on the treatment.

In January, Thousand Oaks, California-based Atara published updated results from this study in Lancet Oncology, which showed an objective response rate of 51.2 percent and an estimated one-year survival rate of 84.4 percent among responders to tab-cel versus a 34.8 percent one-year survival rate among non-responders. The median duration of response was 23 months, and the median overall survival was 18.4 months.

Tab-cel is sold by Pierre Fabre Laboratories in Europe under the brand name Ebvallo as of December 2022. The drug subsequently won marketing authorization in the UK and Switzerland. Last year, Atara and Pierre Fabre expanded their partnership to address tab-cel's development and marketing rights in the US and additional global markets. The original partnership covered Europe, the Middle East, Africa, and other emerging markets.