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SEL120 receives orphan drug designation from FDA

Apr 8, 2020

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On March 29, 2020, the United States Food and Drug Administration (FDA) granted orphan drug designation to SEL120 for the treatment of patients with acute myeloid leukemia.1-2

SEL120 is an oral cyclin-dependent kinase 8 and 19 (CDK8/19) inhibitor. CDK8 and CDK19 play key roles in proliferation and viability of cancer cell lines. SEL120 binding CDK8/19 prevents activation of CDK8/19-mediated oncogenic signaling pathways and inhibits proliferation of CDK8/19-overexpressing tumor cells.SEL120 has shown strong proof of concept in preclinical studies and has received strategic support from the Leukemia & Lymphoma Society through its therapy acceleration program.

  1. S&P Global. Ryvu Therapeutics blood cancer drug gets US FDA orphan-drug tag. Published Mar 29, 2020. Accessed Apr 6, 2020.
  2. FDA grants SEL120 orphan drug designation for acute myeloid leukemia. Published March 31, 2020. Accessed Apr 6, 2020.
  3. Rzymski T, Mikula M, Żyłkiewicz E, et SEL120-34A is a novel CDK8 inhibitor active in AML cells with high levels of serine phosphorylation of STAT1 and STAT5 transactivation domains. Oncotarget. 2017;8(20):33779-33795. DOI: 10.18632/oncotarget.16810


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