BeOne Medicines received US FDA accelerated approval for sonrotoclax, now marketed as Beqalzi, for patients with relapsed or refractory mantle cell lymphoma after treatment with a BTK inhibitor. The company framed the approval as a first-in-class US opportunity for BCL2-targeted therapy in MCL. The accelerated approval follows earlier regulatory progress in China, and BeOne highlighted potential combination strategy data rationale with Brukinsa (zanubrutinib). The company’s positioning centers on pairing its BCL2 inhibitor with BTK inhibition-based regimens in an attempt to improve outcomes in a setting with limited options. BeOne previously described the drug’s mechanism as designed to deepen apoptosis signaling in lymphoma cells while maintaining a differentiated therapeutic approach versus BTK-only therapies.