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# Fast Track Awarded to Leukemia Drug
- URL: https://www.fdaweb.com/fast-track-awarded-to-leukemia-drug/
- Published: 2024-07-15T12:00:00.000Z
- Updated: 2026-09-14T14:35:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157352

FDA has granted Sumitomo Pharma America a fast track designation for DSP-5336 and its use in treating patients with relapsed or refractory acute myeloid leukemia with a KMT2A rearrangement, also known as mixed lineage leukemia rearrangement or nucleophosmin mutation. DSP-5336 is described as a small molecule inhibitor of the menin and mixed-lineage leukemia protein interaction, which plays key roles in gene expression and protein interactions involved in many biological pathways, including cell growth, cell cycle, genomic stability, and hematopoiesis.

The designation is based in part on updated data from the ongoing open-label, dose-escalation and optimization portion of a Phase 1/2 study for DSP-5336 that were [presented](https://c212.net/c/link/?t=0&l=en&o=4210671-1&h=1657822381&u=https%3A%2F%2Fnews.us.sumitomo-pharma.com%2F2024-06-14-Sumitomo-Pharma-Presents-New-Clinical-Data-on-DSP-5336-at-the-European-Hematology-Association-2024-Congress&a=presented&ref=fdaweb.com) at the European Hematology Association 2024 Hybrid Congress. “Objective response was observed in 57% (12/21) of patients, which included responses in patients with both Nucleophosmin 1 (NPM1) mutation and KMT2A (MLL) rearrangement,” the company says. “The proportion with complete remission or complete remission with partial hematologic recovery (CR/CRh) was 24% (5/21 patients).”

The company says that to date, DSP-5336 has been well-tolerated with no dose-limiting toxicity observed and no significant cardiac signal nor treatment-related discontinuations or deaths.