The U.S. Food and Drug Administration has granted accelerated approval to Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The 2 July decision introduces the first bispecific antibody directed at both B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells. Approval was based on results from the Phase 1/2 LINKER-MM1 trial, in which 70 percent of heavily pre-treated patients achieved an objective response and 45 percent reached a complete response. Continued authorisation is contingent on confirmatory studies that verify a clinical benefit. Regeneron set a wholesale acquisition cost of $470 for a 5-milligram vial and $18,800 for a 200-milligram vial and said commercial supply will be available shortly. The product carries boxed warnings for cytokine release syndrome and neurologic toxicity, in line with safety profiles seen across the BCMA bispecific class. Lynozyfic gives Regeneron a foothold in a rapidly expanding market dominated by Johnson & Johnson’s Tecvayli and Pfizer’s Elrexfio, as well as BCMA-targeted CAR-T cell therapies. The company is running additional studies to move the drug into earlier treatment settings.