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FDA granted accelerated approval to linvoseltamab-gcpt, marketed as Lynozyfic by Regeneron, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
The FDA description specifies prior exposure to a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. That places the drug in a late-line setting where treatment options are limited.
Linvoseltamab is a BCMA-directed CD3 T-cell engager, part of a class designed to redirect immune cells toward myeloma cells.
Why It Matters
Multiple myeloma treatment is increasingly shaped by immune redirection therapies, including bispecific antibodies and CAR-T approaches.
What to Watch
Watch safety management, infection risk, treatment sequencing and confirmatory evidence required under accelerated approval.
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