The FDA granted accelerated approval of linvoseltamab-gcpt for certain patients with multiple myeloma.
Specifically, the approval is for patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent and an antiCD38 monoclonal antibody.
Linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals) is a bispecific B-cell maturation antigen-directed CD3 T-cell engager.
“The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community,” Sundar Jagannath,