Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma (R/R MM). The treatment is intended for patients who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have shown disease progression. A final decision from the European Commission is expected in the coming months.

The recommendation is based on data from the LINKER-MM1 trial, which evaluated linvoseltamab in 282 patients. The U.S. FDA has also accepted a Biologics License Application for review, with a decision expected by July 10, 2025.

Linvoseltamab is a BCMAxCD3 bispecific antibody designed to link MM cells with T cells, facilitating immune response. The treatment regimen includes step-up dosing, transitioning to biweekly and eventually monthly administration for responsive patients.

Multiple myeloma, the second most common blood cancer, remains incurable, with patients often requiring additional therapies. Linvoseltamab is part of a broader clinical development program exploring its use in earlier treatment stages and in combination with other therapies.

Regeneron is leveraging its VelociSuite® technologies to develop innovative blood cancer treatments, focusing on bispecific antibodies and emerging modalities. The company continues to push the boundaries of genetic medicine and antibody development to create transformative treatments.