Ascentage Pharma announces China NMPA approval of lisaftoclax

Ascentage Pharma (AAPG) announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax has been approved by China’s National Medical Products Administration for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have previously received at least one systemic therapy including Bruton’s tyrosine kinase inhibitors, which makes lisaftoclax the first Bcl-2 inhibitor receiving conditional approval and marketing authorization for the treatment of patients with CLL/SLL in China, and the second Bcl-2 inhibitor approved globally. This approval is based on the results from a pivotal registrational Phase II study that was designed to evaluate the efficacy and safety of lisaftoclax monotherapy in patients with relapsed or refractory CLL/SLL, with the overall response rate as the primary endpoint. Lisaftoclax demonstrated compelling efficacy and an ORR that met the prespecified endpoint in patients who were previously treated with BTK inhibitors and/or immunochemotherapy. Moreover, lisaftoclax showed a favorable safety profile with no tumor-lysis syndrome occurring during the study, a low incidence of hematologic toxicities which were manageable, and a low incidence of non-hematologic toxicities which were mostly grade 1-2.