BeOne Medicines’ sonrotoclax (branded as Beqalzi) received U.S. FDA accelerated approval for relapsed or refractory mantle cell lymphoma (MCL) after treatment with a BTK inhibitor. The approval follows the drug’s earlier regulatory progress internationally and targets a high-unmet-need population. BeOne said the approval creates a U.S. competitive opening against established MCL regimens, including therapies where BTK inhibition plays a core role. The company highlighted the potential for combination strategies with Brukinsa (zanubrutinib) as an area of commercial focus. From a pipeline standpoint, the clearance strengthens BeOne’s position in the BCL2 inhibitor space and adds another next-generation option in a lymphoma setting where durability and sequencing remain central to treatment decisions.