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U.S. FDA grants Fast Track designation to DSP-5336 for the treatment of R/R AML
DSP-5336, an oral inhibitor of the menin and mixed-lineage leukemia (MLL) interaction, for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML) with a KMT2A rearrangement.1
DSP-5336 is currently under investigation as part of a phase I/II study in patients with relapsed/refractory AML.1 The latest data from this study were presented at the European Hematology Association (EHA) 2024 Hybrid Congress. Data presented highlighted an objective response rate of 57%, which included responses in patients with both nucleophosmin 1 (NPM1) mutation and KMT2A (MLL) rearrangement.1 A complete remission or complete with partial hematologic recovery was observed in 24% of patients.1 There were no dose-limiting toxicities observed, nor cardiac signals or treatment-related discontinuations/deaths.1
- PR Newswire. Sumitomo Pharma Announces that DSP-5336 Has Received FDA Fast Track Designation for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia. https://www.prnewswire.com/news-releases/sumitomo-pharma-announces-that-dsp-5336-has-received-fda-fast-track-designation-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-302196812.html. Published July 15, 2024. Accessed July 16, 2024.
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