The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation for mesutoclax for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. This designation, announced on May 13, 2025, accelerates development for therapies showing significant clinical advantages.
Mesutoclax, an oral BCL2 inhibitor, is tested in the phase 3 trial with orelabrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), according to InnoCare Pharma, the manufacturer of the therapy. Mesutoclax treats MCL and other lymphomas, with strong results in ongoing trials, including one for acute myeloid leukemia, the company wrote in the release.
