Lisaftoclax

Lisaftoclax is an investigational new drug being developed by Ascentage Pharma for the treatment of hematological malignancies, particularly chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is a selective inhibitor of the B-cell lymphoma 2 (BCL-2) protein, designed to restore the normal process of programmed cell death (apoptosis) in cancer cells.[1][2][3] As of 2024, lisaftoclax is undergoing multiple Phase 3 clinical trials, including studies in combination with BTK inhibitors for relapsed/refractory CLL/SLL.[2][4]

In July 2025, lisaftoclax was approved in China for the treatment of CLL or SLL in adult patients who had received at least one prior systemic therapy.[5]

## References

1. ↑ "Lisaftoclax (APG-2575) Is a Novel BCL-2 Inhibitor with Robust Antitumor Activity in Preclinical Models of Hematologic Malignancy". Clinical Cancer Research 28 (24): 5455–5468. December 2022. doi:10.1158/1078-0432.CCR-21-4037. PMID 36048524.
2. ↑ 2.0 2.1 "FDA Grants Clearance for Phase 3 Study of Lisaftoclax in Previously Treated CLL/SLL". 7 August 2023. https://www.onclive.com/view/fda-grants-clearance-for-phase-3-study-of-lisaftoclax-in-previously-treated-cll-sll.
3. ↑ "Ascentage Pharma Announces New Drug Application for Lisaftoclax". PR Newswire (Press release). Retrieved 2024-11-23.
4. ↑ "FDA Clears Phase 3 Trial of Lisaftoclax in CLL/SLL". 8 August 2023. https://www.targetedonc.com/view/fda-clears-phase-3-trial-of-lisaftoclax-in-cll-sll.
5. ↑ "Lisaftoclax: First Approval". Drugs 85 (12): 1635–1642. 2025. doi:10.1007/s40265-025-02251-4. PMID 41060518.

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