Sumitomo Pharma America Announces Enzomenib (DSP-5336) Receives FDA Breakthrough Therapy Designation for Treatment of R/R KMT2A-Rearranged Acute Leukemia

What happened: Sumitomo Pharma America announced that the FDA granted Breakthrough Therapy designation to enzomenib (DSP-5336) for relapsed/refractory acute leukemia with KMT2A rearrangement. Key numbers: Designation announced October 26, 2026. Prior FDA designations: orphan drug for AML in June 2022, Fast Track in June 2024, orphan drug for ALL in July 2026. Why it matters: The designation provides enhanced FDA interaction and guidance during development, and the company said it enables expedited review that may bring the investigational treatment to patients more quickly.

Sumitomo Pharma America announced that the FDA granted Breakthrough Therapy designation to enzomenib (DSP-5336) for relapsed/refractory acute leukemia with KMT2A rearrangement.

The designation provides enhanced FDA interaction and guidance during development, and the company said it enables expedited review that may bring the investigational treatment to patients more quickly.