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ASH 2020

Bcl-2 inhibitor APG-2575 receives FDA orphan drug designation for the treatment of AML

By Claire Baker
Jan 11, 2021
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On January 4, 2021, APG-2575 was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with acute myeloid leukemia.1

APG-2575, a novel Bcl-2 inhibitor, can be administered orally and is being evaluated in a number of hematological malignances through international Phase Ib/II trials. The selective inhibition of Bcl-2 is hypothesized to reinstate functional apoptosis in malignant cells.2 APG-2575 has also received orphan drug designation for the following indications:

  • Waldenström’s macroglobulinemia
  • Chronic lymphocytic leukemia
  • Multiple myeloma

  1. PRNewswire. Ascentage Pharma announces its 9th orphan drug designation from the US FDA in 2020, setting a record for Chinese biopharmaceutical companies. https://www.prnewswire.com/news-releases/ascentage-pharma-announces-its-9th-orphan-drug-designation-from-the-us-fda-in-2020-setting-a-record-for-chinese-biopharmaceutical-companies-301200596.html. Published Jan 4, 2021. Accessed Jan 7, 2021.
  2. PRNewswire. Ascentage Pharma's Bcl-2 Inhibitor APG-2575 granted orphan drug designation by the FDA for the treatment of chronic lymphocytic leukemia. https://www.prnewswire.com/news-releases/ascentage-pharmas-bcl-2-inhibitor-apg-2575-granted-orphan-drug-designation-by-the-fda-for-the-treatment-of-chronic-lymphocytic-leukemia-301124971.html. Published Sep 7, 2020. Accessed Jan 7, 2021.

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