Raritan, New Jersey, U.S., September 18, 2026
Johnson & Johnson has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of TECVAYLI® (teclistamab) for adults with relapsed and refractory multiple myeloma who have received at least one prior line of therapy and are refractory to lenalidomide. The recommendation would expand the European treatment setting for teclistamab beyond its current later-line use and follows results from the Phase 3 MajesTEC-7 study, which evaluated teclistamab in combination with daratumumab and lenalidomide in patients with newly diagnosed multiple myeloma who were not candidates for autologous stem cell transplantation.
Johnson & Johnson Advances TECVAYLI in Earlier Myeloma
The CHMP recommendation would allow TECVAYLI (teclistamab) to be used in a broader population of patients with relapsed and refractory multiple myeloma. Under the proposed indication, eligible adults would have received at least one previous treatment and would need to have disease that is refractory to lenalidomide. Multiple myeloma is a blood cancer affecting plasma cells, a type of immune cell found primarily in the bone marrow. The disease can return after treatment, and patients whose disease becomes resistant to available therapies can face increasingly limited treatment options.
TECVAYLI is a bispecific antibody designed to simultaneously bind BCMA (B-cell maturation antigen) on multiple myeloma cells and CD3 on T cells. By bringing T cells into close proximity with malignant plasma cells, teclistamab is designed to activate the immune system against the cancer cells. The proposed European expansion is significant because the treatment would become available earlier in the treatment sequence for certain patients. The CHMP recommendation, however, is not the final European Union marketing authorisation. The European Commission must make the final legally binding decision following the positive CHMP opinion.
MajesTEC-7 Trial Supports Earlier TECVAYLI Use
Advertisement
The regulatory recommendation is supported by results from the Phase 3 MajesTEC-7 trial, which evaluated teclistamab in combination with daratumumab and lenalidomide in patients with newly diagnosed multiple myeloma who were ineligible for autologous stem cell transplantation. According to Johnson & Johnson, the study demonstrated a statistically significant improvement in progression-free survival (PFS) for the teclistamab combination compared with daratumumab plus lenalidomide. PFS measures the length of time patients remain alive without their disease worsening.
The trial also evaluated other outcomes, including overall response rate, depth of response, and safety. The combination produced high levels of response in the studied population, supporting continued investigation of teclistamab-based regimens across different stages of multiple myeloma treatment. The CHMP recommendation specifically concerns patients with relapsed and refractory disease following at least one prior therapy, while the clinical evidence underlying the broader development program includes studies across different treatment settings. Regulatory decisions are based on the totality of evidence submitted for the specific indication under review.
TECVAYLI Targets BCMA and Expands Myeloma Care
TECVAYLI’s mechanism represents a different approach from conventional chemotherapy because it uses a patient’s own T cells to recognize and attack multiple myeloma cells. BCMA is highly expressed on malignant plasma cells and has therefore become an important target for newer multiple myeloma therapies. Teclistamab is already authorised in the European Union for certain adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and whose disease has progressed on the last therapy. The proposed indication would move TECVAYLI into an earlier line of treatment, potentially allowing eligible patients to receive the BCMA-directed T-cell engager before progressing through multiple later treatment lines.
As a bispecific antibody, TECVAYLI is associated with immune-mediated adverse reactions that require clinical monitoring. Important risks include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), as well as infections and reductions in blood-cell counts. Healthcare professionals use specific monitoring and management procedures when administering the treatment. For Johnson & Johnson, the positive CHMP opinion represents another regulatory milestone for TECVAYLI and BCMA-directed therapy in multiple myeloma. If confirmed by the European Commission, the expanded indication would provide an earlier treatment option for eligible patients with relapsed and refractory disease after at least one prior therapy. The development also reflects the continued expansion of T-cell-engaging therapies and immunotherapies in hematologic cancers, particularly multiple myeloma, where BCMA has emerged as a major therapeutic target.
Source: Johnson & Johnson press release
