Atara Biotherapeutics, Inc. (Nasdaq:ATRA) announced Thursday that the U.S. Food and Drug Administration has accepted its Biologics License Application for tabelecleucel (tab-cel) with priority review status.
The application seeks approval for tab-cel as a monotherapy for adult and pediatric patients two years and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. The FDA has set a Prescription Drug User Fee Act target action date of January 10, 2026.
If approved, tab-cel would become the first therapy authorized in the U.S. specifically for EBV+ PTLD. Currently, no FDA-approved treatments exist for this condition.
"The acceptance of the tab-cel resubmission moves us one step closer towards making this first-of-its-kind treatment available to patients in the U.S.," said Cokey Nguyen, President and Chief Executive Officer of Atara, according to the company’s press release.
Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target EBV-infected cells. The application is supported by data from over 430 patients, including the pivotal ALLELE study that demonstrated a 48.8% objective response rate and a favorable safety profile.
The therapy has previously received Breakthrough Therapy Designation from the FDA for treating rituximab-refractory EBV-associated lymphoproliferative disease, as well as orphan drug designation for EBV-positive post-transplant lymphoproliferative disorders.
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