InnoCare Receives Approval for Mesutoclax in R/R Mantle Cell Lymphoma
Tuesday, May 13, 2025
InnoCare Pharma has announced that its B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).
Mesutoclax is an oral BCL2-selective inhibitor being developed as a standalone therapy or in combination with orelabrutinib. Its potential treatment areas include chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), other non-Hodgkin’s lymphomas (NHLs), and acute myeloid leukaemia (AML).
BCL2 plays a key role in controlling cell death, and its abnormal activity is linked to several blood cancers. By blocking BCL2, mesutoclax helps to restore the natural process of cell death in cancer cells.
The designation applies to the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL) in patients previously treated with BTK inhibitors. This is the first time a BCL2 inhibitor has been granted BTD status in China.
Mesutoclax is currently undergoing clinical trials in China and internationally. These include a Phase III study combining mesutoclax with orelabrutinib as a first-line treatment for CLL/SLL, as well as a study for its use in AML.
The Breakthrough Therapy Designation is intended to speed up the development and review of medicines that show clear clinical advantages for serious or life-threatening conditions.
Source: businesswire.com
