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# Orphan Designation for Menarini Leukemia Drug
- URL: https://www.fdaweb.com/orphan-designation-for-menarini-leukemia-drug/
- Published: 2021-11-04T12:00:00.000Z
- Updated: 2026-09-14T17:21:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150515

FDA has granted orphan drug designation for Menarini Group’s SEL24/MEN1703 to treat acute myeloid leukemia (AML). The drug is [described](https://www.marketwatch.com/press-release/menarini-receives-fda-orphan-drug-designation-for-sel24men1703-a-first-in-class-dual-pimflt3-inhibitor-for-the-treatment-of-acute-myeloid-leukemia-2021-11-04?tesla=y&ref=fdaweb.com) as a first-in-class orally available dual PIM/FLT3 inhibitor that is being investigated in the DIAMOND-01 trial as a single agent for treating patients with relapsed/refractory acute myeloid leukemia. Menarini licensed the investigational drug from Ryvu Therapeutics.