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# FDA Partial Hold on Kura Leukemia Trial
- URL: https://www.fdaweb.com/fda-partial-hold-on-kura-leukemia-trial/
- Published: 2021-11-24T12:00:00.000Z
- Updated: 2026-09-14T17:23:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150650

FDA has placed on partial clinical hold a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). The hold is the result of the company’s recent report to the agency about a Grade 5 serious adverse event (patient death) “potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML,” according to the company. Patients currently enrolled may continue to receive KO-539, although no additional patients may be enrolled until the partial clinical hold is resolved, it says. KO-539 is described as a potent and selective menin inhibitor.