China fast-tracks a new CLL/SLL combo therapy. China's drug regulator has granted breakthrough therapy designation to lisaftoclax plus acalabrutinib for treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The combination is being evaluated in the global phase 3 GLORA-2 trial against standard immunochemotherapy, offering a fixed-duration alternative to continuous BTK inhibitor therapy.
A promising new combo gets a regulatory boost in China. China's Center for Drug Evaluation (CDE) has granted breakthrough therapy designation to lisaftoclax (APG-2575) combined with acalabrutinib (Calquence) for adults with previously untreated CLL/SLL. Lisaftoclax is a novel, oral BCL-2 inhibitor — and notably, it became the first China-developed BCL-2 inhibitor approved in China in July 2025, for patients who had already received at least one prior therapy including a BTK inhibitor.
The designation is backed by the ongoing global phase 3 GLORA-2 trial, which is comparing a fixed-duration regimen of lisaftoclax plus acalabrutinib (up to 18 cycles) against standard immunochemotherapy. The rationale: current options like BTK inhibitor monotherapy require continuous treatment and may not achieve deep enough responses, while immunochemotherapy falls short in high-risk patients with genetic features like del(17p) or TP53 mutations.
Key Takeaways:
Why it matters: This designation could accelerate access to a fixed-duration, chemotherapy-free option for CLL/SLL patients — a significant step forward for a disease where long-term continuous therapy remains a major burden.
