Linvoseltamab Receives Positive CHMP Opinion for Multiple Myeloma

According to this press release from Regeneron Pharmaceuticals Inc., "the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (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 applies to patients who have received at least three prior treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, whose disease has progressed.

The decision is based on data from the LINKER-MM1 trial. A final ruling from the European Commission is expected in the coming months. Meanwhile, the FDA is reviewing linvoseltamab, with a decision expected by July 10, 2025. Linvoseltamab remains investigational and is not yet approved by any regulatory authority. Read the full press release from the button below.