On Tuesday, January 6, Johnson & Johnson announced via press release that it has submitted a “Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of Tecvayli® (teclistamab) in combination with Darzalex® subcutaneous formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy.”
“By targeting both BCMA and CD38 to prime and activate the immune system,” the complementary combination of teclistamab and daratumumab SC “enhance immune-mediated response earlier in the treatment journey,” as early as second line — increasing the potential of improving patient outcomes.
According to Johnson & Johnson, the application is supported by data from the Phase 3 MajesTEC-3 study, which “demonstrates a statistically significant improvement in progression-free and overall survival compared to standard treatment.”
The study included 587 patients who were assigned to one of two treatment groups. One group received teclistamab plus daratumumab subcutaneously. The other group received standard treatments that included daratumumab with dexamethasone and either pomalidomide or bortezomib.
After nearly three years of follow-up, patients who received teclistamab plus daratumumab had an 83% lower risk of worsening disease or death, compared with standard treatment. More than 90% of patients who were still doing well at six months remained progression-free three years later.
Serious side effects (Grade 3 or 4) occurred at similar rates in both groups (about 95–97%). The most common serious side effects were low blood cell counts and infections. Infections were common in both groups, though they occurred somewhat more often in patients receiving teclistamab plus daratumumab.
Because the results clearly favored the teclistamab combination, an independent monitoring committee recommended that the study be unblinded. Results from the MajesTEC-3 study were presented as a late-breaking abstract at the 2025 American Society of Hematology Annual Meeting and published simultaneously in The New England Journal of Medicine.
Johnson & Johnson has submitted an application to the U.S. Food and Drug Administration (FDA) to approve this combination treatment for people with relapsed or refractory multiple myeloma. The FDA has granted the therapy Breakthrough Therapy Designation, which helps speed development and review for treatments that may offer major benefits for serious or life-threatening diseases.
To find out more, read the full press release.