11:57 AM EDT, 05/20/2024 (MT Newswires) -- Atara Biotherapeutics ( ATRA ) said Monday it has filed a biologics license application with the US Food and Drug Administration for tabelecleucel, or tab-cel, to treat patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease.

The application is supported by data from trials covering more than 430 patients with multiple life-threatening diseases, with the latest study showing a statistically significant 48.8% objective response rate and a favorable safety profile consistent with previous analyses, the company said.

The FDA has previously granted the immunotherapy targeting virus-infected cells a breakthrough therapy designation and an orphan drug designation, it said.

If approved, the company said tab-cel would be the first approved therapy for the disease in the US.

The FDA's acceptance of the BLA will prompt a $20 million milestone payment to Atara by its partner Pierre Fabre Laboratories, and an additional $60 million upon approval, Atara said.

Tab-cel was granted marketing authorization under the brand name Ebvallo by the European Commission in 2022, by the Medicines and Healthcare Products Regulatory Agency in the UK in 2023, and by Swissmedic in Switzerland just this month, according to Atara.

Shares of Atara climbed nearly 5% in recent trading.

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