Johnson & Johnson received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for Tecvayli (teclistamab). The recommendation supports its use as a monotherapy for adults with relapsed and refractory multiple myeloma.
This expansion shifts the treatment to a second-line setting for patients who have received at least one prior therapy. Previously, the drug was approved only for later-stage patients.
The Phase 3 MajesTEC-9 study supports this recommendation. Results showed teclistamab significantly improved progression-free survival and overall survival compared to the standard of care. This marks the second Phase 3 study to demonstrate benefits for a Tecvayli-based regimen in the second-line setting.
The European Commission will now review the CHMP opinion to make a final decision on marketing authorization.