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Cellectis’ UCART22 Granted ODD and RPDD Status by FDA

UCART22 is an allogenic CAR T-cell product candidate for the treatment of Acute Lymphoblastic Leukemia.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug (ODD) and Rare Pediatric Disease Designation (RPDD) Status to Cellectis’ UCART22 product candidate for the treatment of Acute Lymphoblastic Leukemia (ALL). ALL represents about 10% of all leukemia cases in the United States, progresses rapidly, and is typically fatal within weeks or months if left untreated. It is estimated that 6,660 new cases of ALL and 1,560 deaths related to the disease occurred in the US in 20222. U...

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