Sumitomo Pharma Oncology’s DSP-5336 Receives the US FDA’s Orphan Drug Designation for the Treatment of Acute Myeloid Leukemia


The US FDA has granted ODD to DSP-5336 which is currently being studied in a P-I/II dose escalation & dose expansion study for patients with r/r AML with/out MLL rearrangement or NPM1 mutation across the US & Japan
In preclinical studies, patients treated with DSP-5336 showed selective growth inhibition in human acute leukemia cell lines with MLL rearrangements or NPM1 mutations
DSP-5336 is a small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein. The therapy is designed to identify novel therapeutic options to improve patients outcomes for the treatment of AML

Ref: PR Newswire | Image: Sumitomo Pharma