Johnson & Johnson received European Commission approval for an expanded indication of its cancer drug TECVAYLI (teclistamab). The approval authorizes the drug's use in combination with daratumumab for adults with relapsed or refractory multiple myeloma. This decision allows the immunotherapy combination to be used as early as the second line of treatment for patients who have received at least one prior therapy.
The Phase 3 MajesTEC-3 study provided the clinical data for this approval. Results showed the combination therapy significantly reduced the risk of disease progression or death compared to standard care regimens. The study demonstrated that the teclistamab and daratumumab combination provides durable disease control.
This steroid-sparing, off-the-shelf treatment option offers a new approach for managing this form of blood cancer.