Pharmaceutical Technology

FDA priority review advances Atara’s tabelecleucel for viral infection

Approval of tabelecleucel would mark the first available therapy for the treatment of EBV+PTLD in the US.

Atara Biotherapeutics has announced that the US Food and Drug Administration (FDA) has awarded a priority review for its biologics license application (BLA) for Epstein-Barr virus (EBV) therapy candidate tabelecleucel.

Tabelecleucel is an allogenic, T cell immunotherapy designed to identify and eliminate EBV-infected cells. The intravenously administered monotherapy is indicated for the treatment of patients aged two years and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior line of therapy.

Sold under the brand name Ebvallo across European and UK markets, the T cell therapy was first granted marketing authorisation by the European Commission (EC) in December 2022 and the Medicines and Healthcare Products Regulatory Agency (MHRA) in May 2023.

With no approved treatments in this setting, agency approval would mark the availability of a novel treatment option for patients in the US, Atara president and CEO, Pascal Touchon said in the 17 July press release. An approval decision is expected by 15 January 2025.

As an allogenic T cell therapy, Ebvallo is unique in the treatment landscape largely dominated by autologous therapies, an expert told Pharmaceutical Technology. However, with the plethora of advanced tools in synthetic biology, genetic engineering, enhanced potency design switches, and CRISPR, there has been “extremely rapid progress.”

According to GlobalData’s consensus forecasts, Ebvallo stands to generate total sales of $699m in 2030. GlobalData is the parent company of Pharmaceutical Technology.

The BLA is supported by data from the pivotal Phase III ALLELE study (NCT03394365) which evaluated 43 patients who had undergone solid organ transplant or hematopoietic cell transplant. As per a December 2022 press release, treatment with tabelecleucel demonstrated a 51.2% objective response rate (ORR) in 43 patients and a median duration of response of 23 months. The safety and tolerability profile of tabelecleucel was consistent with previously reported data.

Atara, aiming for a label expansion, is also conducting the Phase II EBVision study (NCT04554914) to evaluate the safety and efficacy of tabelecleucel for treating EBV-associated diseases.