T-Cell Engager Gets Accelerated Approval Free

The FDA today granted accelerated approval to linvoseltamab (Lynozyfic, Regeneron) for adults with relapsed or refractory multiple myeloma who have already received at least four therapeutic regimens. The decision to approve linvoseltamab, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, was based on the open-label LINKER-MM1 study, which included 80 patients who had not received BCMA-directed or bispecific T-cell engaging therapy. The objective response rate was 70%, with a duration of response of 89% at 9 months and 72% at 12 months.