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

Jan 8, 2021

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 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. 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:

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