EMA committee recommends teclistamab plus daratumumab for relapsed or refractory multiple myeloma
On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) recommended extending the approved use of teclistamab (Tecvayli®) to include its use in combination with daratumumab for adults with relapsed or refractory myeloma who have received at least one prior therapy.
The CHMP is the European Medicines Agency’s (EMA) committee responsible for evaluating medicines and making recommendations on whether they should be approved for use in the European Union. A positive recommendation from the CHMP still requires formal approval by the European Commission before it can be implemented, a process that typically takes a few months.
Teclistamab is a bispecific antibody that helps the immune system recognise and destroy myeloma cells.
The CHMP recommendation is based on the results of the phase III MajesTEC-3 study, published in the New England Journal of Medicine. The study showed that patients treated with the combination of teclistamab and daratumumab lived longer without their myeloma getting worse compared with those receiving standard treatment. Watch below a patient-friendly video explaining the study, its results and its implications for clinical practice.
If approved, this would be the first authorised treatment combination in the European Union to combine a bispecific antibody with daratumumab for the treatment of myeloma.
Following any European Commission approval, availability will also depend on national assessment, pricing and reimbursement decisions in individual European countries.