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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:
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