The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved a phase 3 clinical trial for ICP-248 (mesutoclax) in combination with orelabrutinib as a first-line therapy for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This approval, announced on February 17, 2025, enables the study to proceed in China.
ICP-248, an oral BCL2 inhibitor, and orelabrutinib, a BTK inhibitor, are administered to target CLL/SLL, according to the press release. The trial builds on a phase 2 study that showed promising efficacy and safety in treatment-naïve patients with CLL/SLL.
The phase 3 study aims to confirm these findings in a larger patient group, according to the company.
