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FDA Approves Teclistamab and Daratumumab For Relapsed or Refractory Multiple Myeloma

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On March 5, 2026, the FDA granted full approval for teclistamab (Tecvayli) combined with daratumumab hyaluronidase-fihj for treating adult patients with relapsed or refractory multiple myeloma who have undergone at least one prior therapy, including a proteasome inhibitor and an immunomodulatory agent. This approval converts teclistamab's previous accelerated monotherapy approval for patients with more extensive prior treatments. Key trials demonstrated significant efficacy and safety, with a notable focus on progression-free and overall survival metrics.

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