A Single-arm, Pivotal Registration Phase II Study of the Efficacy and Safety of APG-2575 Monotherapy in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Latest Information Update: 21 Jul 2025
At a glance
- Drugs Lisaftoclax (Primary)
- Indications Chronic lymphocytic leukaemia
- Focus Registrational; Therapeutic Use
- Sponsors Ascentage Pharma
Most Recent Events
- 10 Jul 2025 According to Ascentage Pharma media release, based on results form APG2575CC201 trial the China's National Medical Products Administration (NMPA) has approved lisaftoclax (APG-2575) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton's tyrosine kinase (BTK) inhibitors.
- 17 Nov 2024 According to Ascentage Pharma media release, company announced that a New Drug Application for lisaftoclax, for the treatment of patients with relapsed or refractory (r/r) CLL/SLL has been accepted and recommended the Priority Review designation by the Center for Drug Evaluation) of China National Medical Products Administration. This NDA is based on results from this pivotal registrational Phase II study in China (APG2575CC201).
- 22 Jan 2024 Planned End Date changed from 1 Jan 2024 to 1 Dec 2024.