European Commission approves J&J's Tecvayli-Darzalex combo for earlier-line multiple myeloma

The European Commission has approved Johnson & Johnson Innovative Medicine's Tecvayli (teclistamab), a BCMA×CD3 bispecific antibody, in combination with daratumumab (Darzalex) for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy.

The indication extension moves the teclistamab-daratumumab combination into an earlier line of treatment. J&J said the approval is based on Phase 3 data showing statistically significant improvements in both progression-free survival and overall survival versus a comparator regimen, positioning the doublet as a potential new standard of care for earlier-line R/R disease in Europe.

Tecvayli was first approved in the EU as a monotherapy for heavily pretreated multiple myeloma; the new combination approval broadens its addressable population and deepens J&J's myeloma franchise, which also includes Darzalep and the GPRC5D-targeted bispecific Talvey (talquetamab).

Source: OncLive, 21 August 2026.