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JBI-802 granted orphan drug designation by the FDA

Jan 10, 2023
Learning objective: After reading this article, learners will be able to cite a new development in the treatment of AML.

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On January 5, 2023, JBI-802, an oral, potent, selective dual inhibitor of two epigenetic targets of the transcriptional regulator CoREST complex, LSD1 and HDAC6, was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with acute myeloid leukemia.1

This designation is based on several relevant preclinical models, including erythroid leukemia, where JBI-802 demonstrated synergistic antitumor activity and a favorable safety profile.1

JBI-802 also received orphan drug designation for the treatment of small cell lung cancer.1 The first-in-human trial evaluating JBI-802 in multiple neuroendocrine tumors is ongoing, with plans to expand into hematologic cancers, including acute myeloid leukemia, essential thrombocythemia, and other myeloproliferative cancers.1

  1. Jubilant Therapeutics. Jubilant Therapeutics Inc. receives orphan drug designation for JBI-802 for acute myeloid leukemia (AML) and small cell lung cancer (SCLC). Published Jan 5, 2023. Accessed Jan 10, 2023.

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