FDA priority review advances Atara's tabelecleucel for viral infections

Atara Biotherapeutics recently announced that the US Food and Drug Administration (FDA) has granted a priority review for its biologics license application (BLA) for tabelecleucel, a therapy aimed at combating the Epstein-Barr virus (EBV). This treatment, known commercially as Ebvallo in Europe and the UK, is an allogenic T cell immunotherapy specifically designed to identify and eradicate EBV-infected cells. The therapy is administered intravenously and is intended for patients aged two years and older who have been diagnosed with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) and have previously received at least one line of therapy.

The European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing authorization to Ebvallo in December 2022 and May 2023, respectively. If the FDA approves this therapy, it would offer a new treatment option for patients in the United States, a significant milestone given there are currently no approved treatments for this condition in the US market. Atara Biotherapeutics’ president and CEO, Pascal Touchon, highlighted this in a press release dated 17 July. The FDA's decision is anticipated by 15 January 2025.

Ebvallo distinguishes itself in the treatment sphere as an allogenic T cell therapy, a domain primarily dominated by autologous therapies. An expert revealed to Pharmaceutical Technology that advancements in synthetic biology, genetic engineering, enhanced potency design switches, and CRISPR have fueled rapid progress in this area, making such innovative treatments possible.

Data from the pivotal Phase III ALLELE study (NCT03394365) underpin the BLA. This study involved 43 patients who had undergone either a solid organ transplant or hematopoietic cell transplant. According to a December 2022 press release, tabelecleucel achieved an objective response rate (ORR) of 51.2% among the participants, with a median duration of response extending to 23 months. The safety and tolerability profile of the therapy was consistent with previous data, indicating a reliable treatment alternative.

Further supporting its case, Atara Biotherapeutics is conducting the Phase II EBVision study (NCT04554914) to evaluate tabelecleucel's safety and efficacy in treating other EBV-associated diseases. This ongoing study aims to expand the therapeutic label of tabelecleucel, potentially broadening its application beyond the current indications.

In summary, the FDA’s priority review of tabelecleucel could herald the introduction of a novel and much-needed treatment for EBV+ PTLD in the United States. With its marketing authorization already secured in Europe and the UK, tabelecleucel stands poised to make a considerable impact on the global healthcare landscape, offering new hope to patients afflicted by this challenging condition.

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