Posted by Michael Wonder on 07 Jan 2026
Johnson & Johnson submits application to the EMA for Tecvayli (teclistamab) in combination with Darzalex (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma
5 January 2026 - The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement in progression-free and overall survival compared to standard treatment.
Johnson & Johnson today announced the submission of a Type II variation application to the EMA seeking approval for an indication extension of Tecvayli (teclistamab) in combination with Darzelax subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least one prior therapy.
