J&J Applies for Extension of Multiple Myeloma Therapy's Indication in EU

08:30 AM EST, 01/06/2026 (MT Newswires) -- Johnson & Johnson (JNJ.F) is seeking the European Medicines Agency's approval for an indication extension of its Tecvayli combination therapy for the treatment of adult patients with relapsed/refractory multiple myeloma, who received at least one prior therapy. The pharmaceutical giant's type II variation application is based on the results of the phase 3 MajesTec-3 trial, where treatment with Tecvayli, or teclistamab, plus the Darzalex subcutaneous formulation reduced the risk of disease progression or death by 83.4% after nearly three years, compared with standard regimens, according to a Tuesday release. In 2022, the European Commission cleared Teclistamab for the treatment of patients with relapsed/refractory multiple myeloma, who received at least three prior therapies and demonstrated disease progression. It was also approved for a type II variation application for a reduced dosing option in 2023.