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China NMPA issue breakthrough therapy designation to APL-106 for relapsed/refractory AML

Jan 8, 2021
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On January 7, 2021, the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) granted the E-selectin inhibitor APL-106 breakthrough therapy designation for the treatment of patients with relapsed/refractory (R/R) acute myeloid leukemia (AML).

The agent received investigational new drug approval in September 2020, which provided grounds for a future phase III bridging study of APL-106 in combination with chemotherapy for the treatment of R/R AML.1

APL-106

APL-106 is a first-in-class, investigational, targeted inhibitor of the E-selectin adhesion molecule.1 E-selectin is expressed in the bone marrow endothelium and is essential for physiological hematopoietic turnover. Upon interaction with AML cells, however, E-selectin can promote survival and regeneration, and is now a recognized contributor to AML chemoresistance.2

This newly introduced designation is designed to hasten the development and health authority review of APL-106 in R/R AML. Further research will demonstrate whether this new drug provides an advantage over existing treatment options.

  1. APL-106 (uproleselan) granted breakthrough therapy designation in China for the treatment of acute myeloid leukemia. https://www.globenewswire.com/news-release/2021/01/07/2154803/0/en/APL-106-uproleselan-Granted-Breakthrough-Therapy-Designation-in-China-for-the-Treatment-of-Acute-Myeloid-Leukemia.html. Published Jan 7, 2021. Accessed Jan 7, 2021.
  2. Barbier V, Erbani J, Fiveash C, et al. Endothelial E-selectin inhibition improves acute myeloid leukaemia therapy by disrupting vascular niche-mediated chemoresistance. Nat Commun. 2020;11:2042. DOI: https://doi.org/10.1038/s41467-020-15817-5

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