The US Food and Drug Administration has granted Breakthrough Therapy designation to enzomenib (DSP-5336) for the treatment of patients with relapsed or refractory acute leukemia with a KMT2A rearrangement, according to the developer of the drug, Sumitomo Pharma America.
The designation was granted based on preliminary findings from the ongoing phase 1/2 Horizen-1 study (NCT04988555). Clinical trial evidence indicated that the therapy may demonstrate substantial improvement over available options on clinically significant endpoints, according to a press release from Sumitomo Pharma America.
In June 2024, the FDA also granted Fast Track designation to enzomenib for relapsed or refractory acute myeloid leukemia with KMT2A rearrangements or NPM1 mutations.
In addition to the phase 1/2 Horizen-1 study, enzomenib is being evaluated in the ongoing phase 1/2 DSP-5336-101 clinical trial for patients with newly diagnosed and R/R acute myeloid leukemia.
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