Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from Health Canada to conduct a Phase Ib clinical study of its third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI), olverembatinib (HQP1351), for drug-resistant chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).
Study Details
The open-label, multi-center, randomized, global Phase Ib study will assess the safety, efficacy, and pharmacokinetics of olverembatinib in CML chronic phase (CP), accelerated phase (AP), and blast phase (BP) patients, as well as Ph+ALL patients who are resistant and/or intolerant to at least two TKIs. The study aims to determine the recommended Phase II dosage.
Drug Profile
Olverembatinib, a Category 1 innovative drug, received conditional market approval in China on November 25, 2021, for use in CML CP/AP with T315I mutation resistant to other TKI treatments. Earlier this month, the drug obtained priority review status for the treatment of CML CP patients resistant to or intolerant of first- and second-generation TKIs.-Fineline Info & Tech
