FDA Approves Sonrotoclax (Beqalzi) for Relapsed/Refractory Mantle Cell Lymphoma — First BCL-2 Inhibitor Approved Specifically for MCL

The FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA) for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of therapy including a BTK inhibitor. Based on results from trial BGB-11417-201 (NCT05471843), the overall response rate was 52% (95% CI: 42-62%) in 103 patients, with median time to response of 1.9 months and a median duration of response of 15.8 months. Sonrotoclax is a next-generation BCL-2 inhibitor engineered for greater potency and selectivity than venetoclax (Venclexta), with a distinct molecular binding profile designed to improve both efficacy and tolerability in lymphoma settings. This is the first and only BCL-2 inhibitor approved specifically for MCL — a B-cell lymphoma subtype that is typically incurable with standard chemoimmunotherapy, with median survival of 3-4 years. BTK inhibitor-refractory MCL represents one of the most challenging unmet needs in hematologic oncology, as most patients lack durable remissions after resistance develops to ibrutinib or acalabrutinib. By inhibiting BCL-2, a key anti-apoptotic protein overexpressed in MCL, sonrotoclax circumvents the BTK-dependent survival pathway and triggers programmed cell death in resistant lymphoma cells. Continued approval is contingent on verification of clinical benefit in a confirmatory trial. BeOne Medicines (previously BeiGene) has positioned sonrotoclax as a foundational asset across multiple B-cell malignancy indications.