J&J's Tecvayli wins EC approval as second-line myeloma monotherapy
Johnson & Johnson has secured a European Commission indication extension for Tecvayli (teclistamab), clearing the bispecific antibody for use as a monotherapy in adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy. The decision, announced on 23 October 2026, means teclistamab is now available in the second-line setting through both monotherapy and combination approaches, following the EC's August 2026 approval of teclistamab plus daratumumab in the same broad population.
The approval rests on data from the Phase 3 MajesTEC-9 study (NCT05572515), which compared teclistamab monotherapy against two standard-of-care doublet regimens: pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd). Enrolled patients had received one to three prior lines including lenalidomide and an anti-CD38 monoclonal antibody, making this a population already exposed to two of the most widely used drug classes in myeloma.
Trial data
The headline results, published in the New England Journal of Medicine in 2026, showed a 71% reduction in the risk of disease progression or death (hazard ratio 0.29; 95% CI 0.23–0.38; p less than 0.001) and a 40% reduction in the risk of death (HR 0.60; 95% CI 0.43–0.83; p = 0.002) for teclistamab versus standard of care. The 18-month progression-free survival rate was 69.8% with teclistamab compared with 26.9% for comparator regimens. Nearly two-thirds of patients (65.9%) achieved a complete response or better, against 16.8% in the control arm.
Cyrille Touzeau, Professor at the University Hospital of Nantes and a MajesTEC-9 investigator, said the results "demonstrate the depth of response achieved in the study," adding that the approval gives physicians "an additional immunotherapy option in the second-line setting, supported by significant improvements in both progression-free and overall survival."
The updated label introduces a simplified dosing schedule, with the option to move to monthly maintenance dosing from month seven onwards. Eligible patients may transition to monthly dosing as early as month three, a change J&J says is designed to reduce treatment burden.
On safety, the grade 3 or 4 adverse event rate was 84.9% for teclistamab versus 76.3% for the comparator arms. Grade 5 events occurred in 6.5% of teclistamab recipients compared with 3.5% on standard of care. Infection rates were higher with teclistamab, though the company noted that grade 3 or higher infections decreased over time.
Market context
The approval marks a meaningful shift in the myeloma treatment landscape, where bispecific T-cell engagers are moving from heavily pre-treated settings toward earlier lines of therapy. Teclistamab first received EC approval in August 2022 as a third-line-plus option; the new indication positions it alongside elranatamab (Pfizer's BCMA-targeting bispecific) and talquetamab, which targets GPRC5D, as products competing for earlier market access in a disease area with high unmet need.
Multiple myeloma is one of the most commercially significant haematological malignancies in Europe, with the European Cancer Information System estimating more than 35,000 new diagnoses and approximately 21,900 deaths in the EU in 2024. Achieving durable remissions at first relapse is a recognised priority, as response rates and remission duration typically decline with each successive treatment line.
The broader competitive picture is evolving quickly. Several bispecific antibody combinations and CAR-T programmes are in Phase 2 and Phase 3 evaluation in the second-line setting, and health technology assessment bodies across Europe will need to weigh the survival gains from MajesTEC-9 against the higher infection burden and cost of a subcutaneous bispecific antibody delivered over a prolonged treatment duration. Payer negotiations in individual member states will determine how quickly the expanded indication translates into real-world access for patients at first relapse.