EU Medicines Agency Panel Backs Indication Extension Approval for Johnson & Johnson's Multiple Myeloma Drug

08:27 AM EDT, 09/18/2026 (MT Newswires) -- Johnson & Johnson (JNJ.F) secured a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use to extend the indication for Tecvayli, or teclistamab, as treatment for adults with relapsed/refractory multiple myeloma with at least one previous therapy. The pharmaceutical company said Friday the positive opinion is backed by the results of the phase 3 MajesTEC-9 study evaluating the efficacy and safety of the bispecific antibody as a monotherapy in patients with relapsed/refractory multiple myeloma who received one to three prior therapies, compared with pomalidomide, bortezomib and dexamethasone or carfilzomib and dexamethasone. The European Commission previously approved teclistamab combined with daratumumab to treat patients with relapsed or refractory multiple myeloma who received at least one prior therapy.