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The US FDA has granted BTD to Sumitomo Pharma America’s enzomenib (DSP-5336) for treating pts with R/R acute leukemia with KMT2A rearrangement
Enzomenib is being evaluated as monotx in the registrational P-II (Horizen-1) study in R/R acute leukemia with KMT2A rearrangement or NPM1 mutation & in combination with SoC regimens in newly diagnosed & R/R AML in the P-I/II (DSP-5336-101) trial
Enzomenib is an investigational, oral, small molecule menin-KMT2A interaction inhibitor that previously received the FDA’s FTD for R/R AML with KMT2Ar or NPM1m & ODD for AML & ALL
Ref: Sumitomo Pharma America | Image: Sumitomo Pharma | Press Release
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The post Sumitomo Pharma America’s Enzomenib (DSP-5336) Receives the US FDA’s Breakthrough Therapy Designation for R/R KMT2A-Rearranged Acute Leukemia appeared first on PharmaShots.