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Orelabrutinib receives China’s National Medical Products Administration approval for adult patients with previously untreated CLL/SLL
On April 28, 2025, it was announced that China’s National Medical Products Administration (NMPA) granted approval to orelabrutinib, a second-generation BTK inhibitor, for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) /small lymphocytic leukemia (SLL).1
The approval was based on positive results (complete response rate of 12.1%) from a phase III trial (NCT04578613) of orelabrutinib vs chlorambucil plus rituximab for the treatment of untreated CLL/SLL and follows approvals in China for the treatment of relapsed and refractory (R/R) CLL/SLL, R/R mantle cell lymphoma (MCL), and R/R marginal zone lymphoma (R/R MZL).1,2
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