On 23^th April 2025, the European Commission has granted conditional marketing approval of linvoseltamab to treat adults with relapsed and refractory myeloma. Conditional approval means that linvoseltamab will be reassessed for safety and efficacy when the results of other, larger clinical trials become available.

This approval is based on the favourable recommendation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA – the European medicines licensing body) in February 2025, following the positive results of the LINKER-MM1 study. The CHMP is the EMA committee playing a significant role in the assessment and authorisation of human medicines.

Linvoseltamab is a bispecific monoclonal antibody medicine administered intravenously and marketed by Regeneron as Lynozyfic®. Linvoseltamab works by attaching to two protein targets on the surface of cells: B cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells (immune cells). When linvoseltamab binds to these two targets, it brings immune cells and myeloma cells together to stimulate the killing of the myeloma cells.

Linvoseltamab is indicated for myeloma patients 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 their last therapy.

After teclistamab and elranatamab, linvoseltamab is the third BCMA-CD3 bispecific antibody to be approved in the European Union. Availability of the medicine will depend on the company’s marketing plans and further country level assessments, and pricing and reimbursement decisions.