FDA Grants Fast Track Designation to DSP-5336 for AML

DSP-5336 has received Fast Track Designation from the US Food and Drug Administration (FDA) for relapsed or refractory acute myeloid leukemia (AML) with KMT2A rearrangement, according to a press release from Sumitomo Pharma America, Inc., the manufacturer of the drug.

In an ongoing, phase I/II study presented at the European Hematology Association 2024 Hybrid Congress in Madrid, Spain, the investigational small-molecule inhibitor achieved an objective response rate of 57% and a complete remission or complete remission with partial hematologic recovery rate of 24%.

No dose-limiting toxicities, significant cardiac signals, or treatment-related discontinuations or deaths were observed.

“We are excited by these early results and FDA Fast Track Designation and look forward to working closely with the agency and our collaborators to rapidly advance this program, with the goal of providing a well-tolerated and effective targeted treatment option for patients with relapsed or refractory [AML],” said Jatin Shah, MD, Chief Medical Officer of Oncology at Sumitomo Pharma, in the press release.

Read more: FDA Grants Orphan Drug Designation to Investigational Small-Molecule Inhibitor DSP-5336 for AML