The European Commission approved an expanded indication for Johnson & Johnson’s TECVAYLI (teclistamab) in combination with daratumumab. This treatment targets adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy.
The decision enables the immunotherapy to be used as early as the second line of treatment. This shift addresses the diminishing responses patients typically experience with later-stage therapies.
Data from the Phase 3 MajesTEC-3 study supported the approval. The combination therapy demonstrated statistically significant improvements in both progression-free survival and overall survival compared to standard care.
The combination provides a new off-the-shelf and steroid-sparing option for European physicians. This approach aims to redefine treatment expectations for the RRMM patient population.