Ascentage’s olverembatinib nabs third breakthrough designation from China’s NMPA

Sino-American biopharma Ascentage Pharma (HK: 6855) has announced that olverembatinib has been granted Breakthrough Therapy designation (BTD) by China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), alongside low-intensity chemotherapy, for first-line treatment of newly-diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

This marks the third BTD for olverembatinib in China, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI). 

The first BTD was granted in March 2021 for the treatment of patients with chronic-phase chronic myeloid leukemia resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors, while the second was awarded in June 2023, for the treatment of patients with succinate dehydrogenase-deficient gastrointestinal stromal tumor who had received first-line treatment.