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SLS009 granted Fast Track Designation by the U.S. FDA
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On January 9, 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to SLS009 (formerly GFH009), a highly selective CDK9 inhibitor, for the treatment of patients with relapsed/refractory acute myeloid leukemia.1 SLS009 was previously granted Orphan Drug Designation for the treatment of patients with acute myeloid leukemia.
The safety, tolerability, and efficacy of SLS009 at two dose levels (45 mg and 60 mg) in combination with azacitidine and venetoclax is currently being assessed in a phase IIa trial (NCT04588922).1
- In total, nine patients were enrolled at the 45 mg dose level
- Treatment is ongoing in six patients, and one patient died due to sepsis
- Median overall survival has not been reached
- Overall, a decrease of ≥50% in bone marrow blasts was seen in 87.5% of evaluable patients
- No dose-limiting toxicities have occurred to date
- SELLAS Life Sciences. SELLAS Life Sciences receives FDA Fast Track Designation for SLS009 for treatment of relapsed/refractory acute myeloid leukemia and provides updated data for phase 2a study of SLS009 in relapsed/refractory acute myeloid leukemia patients. https://www.sellaslifesciences.com/investors/news/News-Details/2024/SELLAS-Life-Sciences-Receives-FDA-Fast-Track-Designation-for-SLS009-for-Treatment-of-RelapsedRefractory-Acute-Myeloid-Leukemia-and-Provides-Updated-Data-for-Phase-2a-Study-of-SLS009-in-RelapsedRefractory-Acute-Myeloid-Leukemia-Patients/default.aspx. Published Jan 9, 2024. Accessed Jan 10, 2024.
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