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On October 10, 2023, the U.S. Food and Drug Administration granted orphan drug designation to SLS009 (formerly GFH009), a novel and highly selective CDK9 inhibitor, for the treatment of patients with acute myeloid leukemia (AML).1
The orphan drug designation is based on results from a phase I trial that showed SLS009 to be associated with:
SLS009 is currently being investigated in an open-label, single-arm, multi-center phase IIa trial (NCT04588922) to assess the safety, tolerability, and efficacy of SLS009 at two dose levels (once weekly at 45mg and 60mg) in combination with azacitidine and venetoclax in patients with relapsed/refractory AML.1
In the current AML treatment landscape, when is anti-infection and anti-fungal prophylaxis recommended?
The AML Hub was pleased to speak with Uwe Platzbecker, University of Leipzig Medical Center, Leipzig, DE. We asked, In the current AML treatment...
Visual abstract | Phase III PANTHER trial evaluating pevonedistat + azacitidine vs azacitidine alone in patients with higher-risk MDS or low-blast-percentage AML
The AML Hub is happy to present a visual abstract representing key findings from the...
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