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2w ago

FDA Approves Teclistamab–Daratumumab Combination for Relapsed Multiple Myeloma After One Prior Therapy

The decision follows Phase 3 MajesTEC-3 results that showed an 83% lower risk of progression or death versus daratumumab-based regimens.

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The approval aims to provide a new standard of care and address disease relapse, which affects approximately 40% of patients. Credit: RossHelen / Shutterstock.com.
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Overview

  • The approval authorizes the Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab hyaluronidase-fihj) regimen for adults with relapsed or refractory multiple myeloma after at least one prior line of treatment.
  • In the randomized MajesTEC-3 trial (n=587), the combination was compared with investigator’s choice of daratumumab plus pomalidomide/dexamethasone or bortezomib/dexamethasone, with a median follow-up of about 34.5 months.
  • The study reported significantly improved outcomes with the combo, including a PFS hazard ratio of 0.17 and an OS hazard ratio of 0.46 versus control.
  • Three-year outcomes favored the combination, with PFS of roughly 83% vs 30% and OS of about 83% vs 65% compared with standard regimens.
  • Safety guidance highlights frequent adverse events and a boxed warning for cytokine release syndrome and neurologic toxicity, with serious adverse events in 70.7% of patients; the FDA also converted teclistamab monotherapy to full approval for heavily pretreated patients and used expedited review pathways, including the National Priority Voucher pilot.