FDA grants clearance to next phase of Ascentage Pharma’s clinical trial for CLL/SLL treatment
Betsy Goodfellow | August 8, 2023 | News story | Research and Development | Ascentage Pharma, CLL/SLL, FDA, Oncology, clinical trial
Ascentage Pharma has announced that the US Food and Drug Administration (FDA) has granted clearance for the phase 3 study of lisaftoclax (APG-2575) for the treatment of patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).
This clearance allows the company to take a step forward in the global development of the drug, marking another milestone after the approval of a phase 2 study by the Center for Drug Evaluation (CDE) in China.
The global, multi-centre, randomised, registrational phase 3 study (APG2575CG301) is intended to evaluate the safety and efficacy of lisaftoclax plus a Bruton’s tyrosine kinase inhibitor (BTKi) in patients with CLL/SLL who were previously treated with BTKi. The study is set to begin in the second half of 2023.
Dr Yifan Zhai, chief medical officer of Ascentage Pharma, commented: “With progress in the research and development of targeted therapies, we have seen considerable improvement to the survival of patients with CLL/SLL. However, there remain major clinical challenges and urgent unmet medical needs for novel therapies that are safe and effective. Lisaftoclax, a key drug candidate of our apoptosis-targeted pipeline with global best-in-class potential, has shown promising efficacy and favourable safety in earlier studies. We are very encouraged by the FDA’s clearance for the global registrational phase 3 study as it marks a major milestone in the development of lisaftoclax. Fulfilling the mission of addressing unmet clinical needs in China and around the world, we will press ahead with the global registrational phase 3 study of lisaftoclax (APG-2575) to allow patients around the world to benefit from this novel therapeutic as soon as possible.”
Betsy Goodfellow
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
