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SEL120 receives orphan drug designation from FDA
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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.3 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.
- S&P Global. Ryvu Therapeutics blood cancer drug gets US FDA orphan-drug tag. https://www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/ryvu-therapeutics-blood-cancer-drug-gets-us-fda-orphan-drug-tag-57804730. Published Mar 29, 2020. Accessed Apr 6, 2020.
- FDA grants SEL120 orphan drug designation for acute myeloid leukemia. https://www.healio.com/hematology-oncology/leukemia/news/online/%7B07850139-7cc9-4fd0-b260-b2adc3e1e7cd%7D/fda-grants-sel120-orphan-drug-designation-for-acute-myeloid-leukemia. Published March 31, 2020. Accessed Apr 6, 2020.
- 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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