China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Category 1 drug, olverembatinib. This second market-approved indication is for the treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) who are resistant and/or intolerant to first and/or second-generation tyrosine kinase inhibitors (TKIs).
Olverembatinib’s Expanding Approvals and Designations
Olverembatinib, a third-generation BCR-ABL TKI, was conditionally approved in China on November 25, 2021, for use in chronic phase and accelerated phase chronic myeloid leukemia (CML CP/AP) with T315I mutation, which is resistant to other TKI treatments. In July 2022, the drug was granted priority review status for the indication of CP CML patients resistant to or intolerant of first- and second-generation TKIs. Further, in March 2023, olverembatinib was awarded breakthrough therapy designation for the treatment of succinate dehydrogenase (SDH) deficient gastrointestinal stromal tumors (GIST) that have undergone first-line treatment.- Flcube.com
