Beone Medicines’ next-generation BCL2 inhibitor sonrotoclax received accelerated approval from the US FDA for relapsed or refractory mantle cell lymphoma (MCL) after treatment with a BTK inhibitor. The drug will be branded Beqalzi, marking the first BCL2-targeting therapy in the indication in the US. The approval follows Beone’s earlier regulatory clearance in China for sonrotoclax, and the company highlighted a potential expansion path through combinations, including with Brukinsa (zanubrutinib). For biotech and oncology teams, the approval adds another mechanism to the post-BTK treatment landscape in MCL. Beqalzi’s entry also signals ongoing FDA interest in pathway-based oncology approvals that can move faster when early clinical evidence supports meaningful benefit.