Johnson & Johnson announced the CHMP recommended expanding approval for its cancer drug, TECVAYLI (teclistamab). The recommendation targets adult patients with relapsed and refractory multiple myeloma who have received at least one prior therapy.
This recommendation allows the immunotherapy's use in earlier lines of treatment, potentially as soon as the second line. The CHMP based its decision on positive Phase 3 study results. The study demonstrated TECVAYLI significantly improved progression-free and overall survival compared to standard of care. The European Commission will now review the recommendation for a final marketing authorization decision across the EU.