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2022-10-04T13:32:44.000Z

KITE-222 granted orphan drug designation by the FDA

Oct 4, 2022
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Learning objective: After reading this article, learners will be able to cite a new development in the treatment of AML.

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On September 30, 2022, KITE-222, an investigational chimeric antigen receptor (CAR) T-cell therapy, was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with acute myeloid leukemia (AML).1

This autologous CAR T-cell therapy targets C-type lectin-like molecule-1 (CLL-1). While CLL-1 is expressed in lineage-committed myeloid cells in up to 90% of patients with AML, it is not expressed in healthy hematopoietic stem cells.1

A phase I open-label, multicenter trial evaluating the safety of KITE-222 in patients with relapsed/refractory AML is currently enrolling (NCT04789408).

  1. Kite Pharma. Kite receives U.S. Food and Drug Administration (FDA) orphan drug designation for KITE-222 for acute myeloid leukemia. https://www.kitepharma.com/news/company-statements/kite-receives-us-food-and-drug-administration-fda-orphan-drug-designation-for-kite-222-for-acute-myeloid-leukemia. Published Sep 30, 2022. Accessed Oct 4, 2022

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