The European Medicines Agency (EMA) has recommended a conditional marketing authorisation in the European Union (EU) for teclistamab for the treatment of adult patients with relapsed and refractory myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment.

Teclistamab, alternatively known under the branded name Tecvayli, is a monoclonal antibody that targets two proteins at the same time: a protein called B-cell maturation antigen (BCMA), which is present on the surface of the multiple myeloma cells, and CD3, a protein that is present on T cells (cells of the immune system responsible for destroying abnormal cells). By attaching to BCMA and CD3 at the same time, the medicine activates the T cells to kill myeloma cells.

EMA’s human medicines committee (CHMP) based its recommendation for a conditional marketing authorisation on a phase 1/2, multicentre, open-label, single-arm clinical trial. The study investigated the efficacy and safety of this drug in 165 patients with relapsed or refractory myeloma who had received at least three prior therapies (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) and who didn’t respond to the last treatment regimen. 63% of patients enrolled in the study responded to the treatment and lived without their disease getting worse for about 18 months on average. The most common side effects reported in the clinical trial were hypogammaglobulinaemia (a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high), and cytokine release syndrome (CRS).

Find more information in the press release published by the EMA.