European Commission Approves Tecvyali (teclistamab) in Combination with Daratumumab for Relapsed/Refractory Multiple Myeloma

August 21, 2026—According to a press release from Johnson & Johnson, "the European Commission (EC) has approved an indication extension for TECVAYLI® (teclistamab) in combination with daratumumab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The approval introduces a new treatment option as early as second line for patients living with RRMM."

The approval is based on phase 3 MajecTEC-3 study, (NCT05083169), "which evaluated the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients with RRMM who have received 1–3 prior lines of therapy."

Why This Matters

This approval makes teclistamab plus daratumumab available in Europe as early as the second line of treatment for relapsed or refractory multiple myeloma. It allows patients to benefit from a powerful immunotherapy approach. In the phase 3 MajesTEC-3 trial, the combination reduced the risk of disease progression or death by 83.4% and improved overall survival compared with standard regimens. The disease control was also remarkably durable: More than 90% of patients who were progression-free at six months remained progression-free at three years. As an off-the-shelf regimen that does not require the use of the steroid dexamethasone, the combination could establish a new standard of care and give patients longer, deeper disease control earlier in the course of relapse.

To learn more, read the full press release from the button below.