FDA Approves Teclistamab and Daratumumab For Relapsed or Refractory Multiple Myeloma

On March 5, 2026, the FDA approved teclistamab (Tecvayli) for use with daratumumab hyaluronidase-fihj in adults with relapsed or refractory multiple myeloma after one line of therapy, transitioning from an accelerated to traditional approval. This decision was influenced by the results from the MajesTEC-3 trial, showing improved progression-free survival compared to control treatments. Important safety warnings include risks of cytokine-release syndrome and neurologic toxicity, with teclistamab available through a REMS program.