- Johnson & Johnson submitted a Type II variation application to the EMA for TECVAYLI and DARZALEX in relapsed/refractory multiple myeloma.
- The application is supported by Phase 3 MajesTEC-3 study data showing an 83.4% reduction in disease progression risk.
- The study involved 587 patients and compared TECVAYLI and DARZALEX to standard regimens.
- The FDA granted Breakthrough Therapy Designation for the combination regimen.
EMA Application
Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) for the approval of TECVAYLI (teclistamab) in combination with DARZALEX (daratumumab) subcutaneous formulation. This application targets adult patients with relapsed/refractory multiple myeloma who have undergone at least one prior therapy.
Study Data
The submission is backed by data from the Phase 3 MajesTEC-3 study, which enrolled 587 patients. The study compared the combination of teclistamab and daratumumab SC against standard regimens involving daratumumab SC and dexamethasone with either pomalidomide or bortezomib. Results indicated an 83.4% reduction in the risk of disease progression or death, with a hazard ratio of 0.17.
Adverse Events
Both treatment arms showed similar rates of Grade 3/4 treatment-emergent adverse events, primarily cytopenia and infection. Infections were observed in 96.5% of patients receiving the teclistamab and daratumumab SC combination, compared to 84.1% in the comparator group.
Regulatory Progress
The Independent Data Monitoring Committee recommended unblinding the study due to the statistical significance of the results. The data were presented at the 2025 American Society of Hematology Annual Meeting and published in The New England Journal of Medicine. Additionally, Johnson & Johnson has submitted a supplemental Biologics License Application to the U.S. FDA, which has granted Breakthrough Therapy Designation for the combination regimen.
