FDA Grants Accelerated Approval to Regeneron Lynozyfic for Relapsed Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Regeneron's Lynozyfic (linvoseltamab-gcpt), a BCMAxCD3 bispecific antibody, for adults with relapsed or refractory multiple myeloma (R/R MM) who have undergone at least four prior lines of therapy. This approval is based on data from the Phase I/II LINKER-MM1 trial, which showed a 70% overall response rate and a 45% complete response rate, with durable responses and a median time to first response of less than one month. Updated results from the LINKER-MM2 trial demonstrated that combining linvoseltamab with carfilzomib significantly improved outcomes, achieving a 90% overall response rate and 76% complete response rate, compared to linvoseltamab monotherapy. The FDA label includes warnings about risks such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), but the safety profile was consistent with expectations. Regeneron is further investigating Lynozyfic in earlier treatment settings and other plasma cell disorders, positioning it as a potential new standard of care for multiple myeloma. These developments represent significant progress in addressing unmet needs in heavily pretreated multiple myeloma patients.