Atara Biotherapeutics to Submit New FDA Biologics License Application in 2Q

By Sabela Ojea

Atara Biotherapeutics said it plans to submit a biologics license application for tabelecleucel following productive conversations with the U.S. Food and Drug Administration.

The biopharmaceutical company and the FDA are now aligned and it expects to submit the application in the second quarter of 2024, Atara Biotherapeutics said Tuesday.

The BLA submission for tabelecleucel "will enable Atara to incorporate the latest tab-cel pivotal trial data from the Allele study into the BLA filing package," it said.

Tabelecleucel, approved in the European Union, is being developed for relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease, a rare hematologic cancer.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

September 19, 2023 16:35 ET (20:35 GMT)

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