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FDA Approves Teclistamab and Daratumumab For Relapsed or Refractory Multiple Myeloma

On March 5, 2026, the U.S. Food and Drug Administration (FDA) approved teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for the treatment of adult patients with relapsed or re...

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    FDA approved teclistamab with daratumumab for relapsed/refractory multiple myeloma.

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    Patients need at least one prior therapy to qualify.

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    Full approval converts previous accelerated status.

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    Major trial: MajesTEC-3 - evaluated efficacy and safety.

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    Key outcomes: Progression-free survival and overall survival metrics.

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    Teclistamab has warnings for cytokine-release syndrome and neurological toxicity.

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    Streamlined review via Project Orbis for international collaboration.

Original Source(s)

FDA Approves Teclistamab and Daratumumab For Relapsed or Refractory Multiple Myeloma

  • by The ASCO Post Staff

  • March 24, 2026

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