Beerse, Belgium — March 10, 2026
Global healthcare company Johnson & Johnson has announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval to expand the indication of TECVAYLI® (teclistamab) as a monotherapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The submission represents a significant regulatory milestone for the company’s bispecific antibody immunotherapy and could potentially introduce a new treatment option earlier in the disease pathway for patients facing relapse after frontline therapies. The application is supported by Phase 3 clinical trial data from the MajesTEC-9 study, which demonstrated significant improvements in patient outcomes compared with currently used standard-of-care therapies.
Phase 3 Data Demonstrates Superior Survival Outcomes
The MajesTEC-9 Phase 3 clinical trial evaluated the efficacy and safety of teclistamab monotherapy compared with commonly used treatment regimens including pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd). The study enrolled 614 patients with relapsed or refractory multiple myeloma who had received between one and three prior lines of therapy, many of whom had already developed resistance to widely used treatments such as anti-CD38 monoclonal antibodies and lenalidomide.
Results from the trial demonstrated that teclistamab significantly improved both progression-free survival and overall survival compared with standard therapy. The data showed a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death among patients receiving teclistamab monotherapy. These findings highlight the potential for the therapy to become an important second-line treatment option for patients experiencing early relapse, particularly in populations with limited available treatment choices.
The study’s safety results were also encouraging, with the safety profile of teclistamab remaining consistent with previously reported clinical data and no new safety signals identified. Infections associated with treatment were manageable using established monitoring protocols and supportive care measures including immunoglobulin therapy and antimicrobial prophylaxis. Based on the strength of the interim results, the Independent Data Monitoring Committee recommended unblinding the trial early, reinforcing confidence in the therapy’s clinical effectiveness.
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Expanding Treatment Options for Relapsed Multiple Myeloma
Multiple myeloma is a chronic and currently incurable blood cancer affecting plasma cells in the bone marrow, and patients often experience repeated disease relapse despite advances in treatment. While modern frontline therapies, including anti-CD38 antibody-based quadruplet regimens, have improved survival outcomes, many patients eventually develop resistance to these treatments, leaving clinicians with limited options in later lines of therapy.
The proposed regulatory expansion for TECVAYLI monotherapy could allow clinicians to introduce the therapy earlier in the treatment pathway, potentially improving long-term outcomes for patients who relapse after initial treatment. Teclistamab works as a bispecific antibody that simultaneously targets B-cell maturation antigen (BCMA) on cancer cells and CD3 receptors on T-cells, redirecting the body’s immune system to identify and destroy malignant plasma cells.
Unlike many personalized cell-based immunotherapies, teclistamab is designed as an off-the-shelf subcutaneous injection, meaning it can be administered without complex manufacturing processes required for certain cellular therapies. This characteristic may enable broader accessibility for patients across different healthcare settings while reducing treatment delays.
Advancing the MajesTEC Clinical Development Program
The MajesTEC-9 trial is part of the broader MajesTEC clinical development program, which is investigating the use of teclistamab across multiple treatment settings and in combination with other therapies. In addition to monotherapy studies, ongoing research is exploring the drug’s potential when combined with other anticancer agents in patients with relapsed or refractory multiple myeloma.
Teclistamab previously received European Commission approval in 2022 for patients who had received three or more prior therapies, marking it as one of the first BCMA-targeted bispecific antibodies available for multiple myeloma treatment. Subsequent regulatory updates have also enabled reduced dosing frequency for patients achieving sustained responses, improving treatment convenience and patient quality of life.
The newly submitted application represents the first of several planned global regulatory filings, as Johnson & Johnson continues to expand access to the therapy worldwide. Full clinical data from the MajesTEC-9 trial are expected to be presented at a future major medical meeting, further informing clinicians and researchers about the therapy’s potential role in managing relapsed disease.
As research in immunotherapy and targeted cancer treatments continues to evolve, therapies like teclistamab are helping redefine the treatment landscape for multiple myeloma. By leveraging the body’s immune system to attack cancer cells directly, bispecific antibody therapies are emerging as powerful tools in the fight against blood cancers, offering new hope for patients whose disease has progressed after previous treatments.
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Source: Johnson & Johnson press release
