Linvoseltamab Recommended for EU Approval by the CHMP to Treat R/R Multiple Myeloma
“EMA CHMP has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. The European Commission is expected to announce a final decision in the coming months. The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics License Application for linvoseltamab. The target action date for the FDA decision is July 10, 2025.”
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