The Center for Drug Evaluation of China's National Medical Products Administration granted Ascentage Pharma Group International's (HKG:6855) olverembatinib its third breakthrough therapy designation, a Thursday bourse filing said.
The designation is for the drug's combination with low-intensity chemotherapy for treating newly-diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia, a type of blood cancer caused by a genetic mutation in certain chromosomes.
The drug has been granted breakthrough therapy designation twice before, once in March 2021 for the treatment of patients with chronic-phase chronic myeloid leukemia and then in June 2023 for patients with succinate dehydrogenase-deficient gastrointestinal stromal tumors.
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