Menarini Receives FDA Orphan Drug Designation for SEL24/MEN1703, a first in class, dual PIM/FLT3 inhibitor for the Treatment of Acute Myeloid Leukemia

The Menarini Group announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to SEL24/MEN1703 for the treatment of Acute Myeloid Leukemia (AML). SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor, in-licensed by Menarini from Ryvu Therapeutics, and currently investigated in the DIAMOND-01 trial as a single agent for the treatment of patients with relapsed/refractory AML.

ODD is granted by the FDA to therapies intended for the treatment of conditions that impact fewer than 200,000 people in the US and provides companies with several incentives to support the development of therapeutics and diagnostics for rare diseases. Of note, ODD does not influence the process of regulatory approval, and drugs for rare diseases go through the same rigorous scientific review process established for any other drug.

FDA orphan drug designation represents an important milestone for SEL24/MEN1703 program,” said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. “SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor that can contribute to finding new treatment paradigms for AML where significant unmet needs exist especially as resistance develops in later lines. We look forward to advancing the clinical development of SEL24/MEN1703 in AML with a goal to ultimately provide patients with a new therapeutic option for this hard-to-treat disease.”

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