European Commission Approves Johnson & Johnson's Teclistamab With Daratumumab for Relapsed or Refractory Multiple Myeloma

The EU and US indication statements do not match

Brussels wrote the extension as an indication for adults with relapsed or refractory disease who have received at least one prior therapy. When the FDA cleared the same combination on March 5, it required that the prior line include a proteasome inhibitor and an immunomodulatory agent, and in the same action converted teclistamab monotherapy from accelerated to traditional approval in patients with four or more prior lines. That US review ran under Project Orbis alongside Health Canada and Swissmedic, and through the Commissioner's National Priority Voucher pilot.

What MajesTEC-3 measured

587 patients were randomized, 291 to teclistamab with subcutaneous daratumumab and 296 to daratumumab and dexamethasone plus either pomalidomide or bortezomib. Median progression-free survival was not reached in the combination arm and was 18.1 months (95% CI, 14.6 to 22.8) in the control arm, the FDA notice states. Johnson & Johnson reported the same finding as an 83.4% reduction in the risk of progression or death, and said more than 90% of the 249 patients still free of progression at six months were free of it at three years. Every case of cytokine release syndrome was Grade 1 or 2 and none led to discontinuation, with cytopenia and infection the most common Grade 3/4 treatment-emergent events. Costa and colleagues published the trial in the New England Journal of Medicine in February.

A Salamanca myeloma director on moving the regimen earlier

María-Victoria Mateos, M.D., director of the myeloma unit at the University Hospital of Salamanca, built the case for second line around what each relapse costs.

Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making earlier access to the most effective treatments increasingly important. Today's approval of teclistamab in combination with daratumumab marks an important advance by providing physicians with an off-the-shelf, steroid-sparing, immunotherapy option that has demonstrated meaningful improvements in progression-free and overall survival, with the potential to redefine treatment expectations as early as second line.

Ester in 't Groen, EMEA therapeutic area head for hematology at Johnson & Johnson, called the pairing "a new standard of care for patients in Europe." That is the company's phrase, not the Commission's.

Step-up dosing and the 48-hour rule

Teclistamab bridges BCMA on myeloma cells to CD3 on T cells, and daratumumab binds CD38. The EU product information starts each patient at 0.06 mg/kg subcutaneously, moves to 0.3 mg/kg, then to 1.5 mg/kg weekly, and every step-up dose is preceded one to three hours earlier by dexamethasone 16 mg, an antihistamine and an antipyretic. Patients remain within proximity of a healthcare facility and are monitored daily for 48 hours after each dose in that schedule, and they are told not to drive during it. The schedule cannot be started in a patient with an active infection, and Grade 2 or higher ICANS returns the patient to daily 48-hour monitoring on the next dose.

Why This Matters to the APO|APE Reader

Teclistamab reached the EU market in August 2022 under a conditional marketing authorization, renewed on June 12, 2026, and the specific obligation attached to it is delivery of study 64007957MMY3001, the trial behind this approval, by March 2028. The product information posted by the EMA as of Aug. 22 still lists the monotherapy indication only, so hospital pharmacy and prescribing teams working from that annex will not yet find the doublet in it. Reimbursement is decided country by country, and the announcement names no member state.