Beerse, Belgium, August 21, 2026
Johnson & Johnson announced that the European Commission (EC) has approved an indication extension for TECVAYLI® (teclistamab) in combination with daratumumab for adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The decision introduces a new treatment option as early as the second line of treatment, potentially expanding access to an off-the-shelf immunotherapy approach for patients whose disease has returned or failed to respond adequately to earlier treatment. The approval is supported by results from the Phase 3 MajesTEC-3 clinical trial, which demonstrated statistically significant improvements in both progression-free survival and overall survival compared with standard-of-care regimens
European Commission Expands TECVAYLI Treatment Option
The European Commission’s decision broadens the role of teclistamab, a BCMAxCD3 bispecific antibody, in the treatment landscape for multiple myeloma. TECVAYLI is designed to redirect a patient’s T cells toward malignant plasma cells by simultaneously targeting BCMA on myeloma cells and CD3 on T cells, activating the immune system to attack cancer cells. When combined with daratumumab, which targets CD38 and contributes to immune-mediated activity against myeloma cells, the two therapies provide complementary mechanisms of action. According to Johnson & Johnson, this combination may offer meaningful long-term disease control earlier in the treatment journey, when treatment decisions can have a significant influence on disease progression.
Phase 3 Data Show Major Survival Benefits
The regulatory decision is based on results from the MajesTEC-3 Phase 3 study, an ongoing randomized clinical trial evaluating teclistamab plus subcutaneous daratumumab against investigator-selected standard-of-care regimens consisting of daratumumab, dexamethasone and either pomalidomide or bortezomib. The study enrolled patients with RRMM who had received one to three prior lines of therapy. The results showed a substantial reduction in the risk of disease progression or death. At nearly three years of follow-up, the combination reduced the risk by 83.4% compared with standard of care, with a hazard ratio of 0.17 and statistical significance at p<0.001. The durability of the response was another important finding. More than 90% of patients who remained progression-free at six months were still progression-free at three years, highlighting sustained disease control with the combination. Overall survival also favored teclistamab plus daratumumab, with a hazard ratio of 0.46 and p<0.0001. At three years, the reported overall survival rate was 83.3% with the combination compared with 65.0% with standard care, while the treatment benefit was observed across all prespecified patient subgroups. These findings strengthen the clinical rationale for moving the combination into earlier lines of therapy for RRMM.
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Manageable Safety Profile Supports Combination Therapy
The safety findings from MajesTEC-3 were consistent with the established safety profiles of the individual therapies, and no new safety signals were identified. All reported cases of cytokine release syndrome were Grade 1 or Grade 2 and did not result in treatment discontinuation. The most frequently observed Grade 3 or Grade 4 treatment-emergent adverse events included cytopenia and infections. Treatment discontinuations caused by treatment-emergent adverse events remained relatively low and occurred at similar rates between the treatment groups, at 4.6% for the teclistamab combination and 5.5% for the comparator regimen. The approval represents an important development in multiple myeloma treatment, a blood cancer characterized by abnormal plasma-cell proliferation in the bone marrow. Patients with RRMM frequently experience progressively shorter remissions and increasing treatment resistance with each relapse. By enabling the use of a bispecific antibody-based combination as early as second line, the European Commission’s decision could provide physicians with another therapeutic strategy for managing patients whose disease has returned after initial treatment.
Source: Johnson & Johnson press relese
