Cancer ResearchFDA Approves Sonrotoclax for Hard-to-Treat Mantle Cell Lymphoma
The FDA granted accelerated approval on May 13, 2026 to sonrotoclax (Beqalzi), a BCL-2 inhibitor developed by BeOne Medicines, for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of therapy, including a BTK inhibitor. Mantle cell lymphoma is an aggressive blood cancer with limited options after BTK inhibitor failure, making this approval clinically significant. Sonrotoclax works by blocking BCL-2, a protein that cancer cells exploit to resist programmed cell death, effectively restoring the body's ability to eliminate malignant B-cells. The accelerated approval pathway reflects promising early efficacy data, with full approval contingent on confirmatory trial results. This adds a meaningful new tool to the oncologist's arsenal for a patient population with few remaining options.
