Johnson & Johnson has submitted an application to the European Medicines Agency to expand the use of Teclistamab (Tecvayli) for patients with relapsed or refractory Multiple Myeloma. The request seeks to move the therapy from a fourth-line treatment to a second-line option, allowing patients to receive the immunotherapy earlier in their treatment course.
The application is based on results from the Phase 3 MajesTEC-9 clinical trial, which compared teclistamab with standard treatments such as pomalidomide/bortezomib/dexamethasone or carfilzomib/dexamethasone. The study found that teclistamab significantly improved outcomes, reducing the risk of disease progression or death by 71% and lowering the risk of death by 40% compared with standard therapies. Researchers say these findings suggest that using the drug earlier could meaningfully change the course of the disease.
Teclistamab has been approved in the European Union since 2022 for patients who have already received at least three prior treatments. The new submission aims to expand its use to patients who have received only one prior therapy, provided they were previously treated with an anti-CD38 antibody and lenalidomide. If approved, the change could make teclistamab available much earlier for patients with relapsed or refractory multiple myeloma.