The European Commission approved an expanded indication for Johnson & Johnson's Tecvayli (teclistamab). Tecvayli is approved as a monotherapy for adults with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least one prior treatment. This decision makes Tecvayli available as early as a second-line treatment option.
The Phase 3 MajesTEC-9 study supported this approval. The study demonstrated teclistamab monotherapy reduced the risk of disease progression or death by 71%. This reduction was observed compared to standard care. It also showed a 40% reduction in the risk of death. This follows a recent EU approval for Tecvayli in combination with daratumumab. That approval was for a similar patient group.