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CAR T Therapy for AML Receives Orphan Drug Designation

December 2, 2022

December 2022

The U.S. Food and Drug Administration (FDA) granted orphan drug designation to KITE-222, a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) in adults.

The treatment is designed to specifically target C-type lectin-like molecule-1, which is expressed on malignant cells in approximately 90% of AML cases. KITE-222 has demonstrated the ability to clear AML cells in aggressive tumor models in pre-clinical trials, and the sponsor is currently enrolling adult participants with R/R AML in a multicenter phase I trial.

The open-label, single-group study is designed to evaluate the safety and efficacy of KITE-222 with primary and secondary outcomes including composite complete remission, overall remission rate, relapse-free survival, event-free survival, overall survival, dose limiting toxicities, and adverse events.

“The FDA’s decision to grant this designation to KITE-222 reflects the urgent need to develop novel therapeutics for people living with AML – a devastating disease with poor prognosis,” said Frank Neumann, MD, PhD, Kite’s global head of clinical development.

Sources: Kite Pharma, September 30, 2022; ClinicalTrials.gov, March 9, 2021.

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