Sumitomo Pharma Oncology Receives Orphan Drug Designation for DSP-5336, an Investigational Menin and Mixed-Lineage Leukemia Binding Protein for Treatment of Acute Myeloid Leukemia

August 11, 2022

Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics has announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, for the treatment of acute myeloid leukemia (AML). 

“We are pleased to have received this designation for DSP-5336 which reinforces the need to identify novel therapeutic options to improve outcomes for patients with AML,” said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Pharma Oncology, Inc. “We are excited to contribute to the advancement of research in this hematologic malignancy.”  

DSP-5336 is currently being evaluated in a Phase 1/2 clinical trial to evaluate the safety and efficacy of DSP-5336 in patients with Relapsed/Refractory AML/ ALL with or without MLL Rearrangement or NPM1 Mutation, which is being conducted in the United States and Japan. To learn more about the study and eligibility for enrollment, visit clinicaltrials.gov (NCT04988555).