Posted by Michael Wonder on 11 Mar 2026
Tecvayli (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy
10 March 2026 - Johnson & Johnson today announced the submission of a type II variation application to the EMA seeking approval for an indication extension of Tecvayli (teclistamab) as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least one prior therapy.
The submission is supported by data from the Phase 3 MajesTEC-9 trial evaluating the efficacy and safety of teclistamab versus the standard of care of pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone in 614 patients with relapsed/refractory multiple myeloma.
