BeOne Medicines’ sonrotoclax (sonrotoclax/Beqalzi) won US accelerated approval for relapsed or refractory mantle cell lymphoma after a BTK inhibitor, giving the company a first US BCL2-labeled option in that setting. The approval positions BeOne to test combinations with BTK inhibitors such as zanubrutinib (Brukinsa) as clinicians look for deeper disease control following BTK exposure. The accelerated approval also reflects the FDA’s continued willingness to expand targeted options in post–BTK populations using surrogate endpoints. For payers and clinicians, it adds a new decision point in the treatment sequencing of MCL after BTK inhibitors, where options have remained limited. BeOne previously reported earlier regulatory progress internationally; with this US green light, the company can now move forward with broader access planning and confirmatory strategy discussions aimed at converting accelerated approval to full approval as data mature.