Ascentage Pharma says olverembatinib granted BTA by China’s CDE

Ascentage Pharma (AAPG) announced that its drug, olverembatinib, has been granted a Breakthrough Therapy Designation by the Center for Drug Evaluation of China’s National Medical Products Administration, for combination with low-intensity chemotherapy for the first-line treatment of newly-diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. This marks the third BTD granted to olverembatinib in China, with the first BTD 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; and the second BTD granted in June 2023, for the treatment of patients with succinate dehydrogenase-deficient gastrointestinal stromal tumor who had received first-line treatment.