FDA Approves Johnson & Johnson's Ready To Use Cell Therapy For Multiple Myeloma

  • The FDA approved Janssen Pharmaceutical's, a unit of Johnson & Johnson JNJ, Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy.
  • Tecvayli is a first-in-class, bispecific T-cell engager antibody administered as a subcutaneous treatment.
  • This indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Tecvayli is Janssen's fourth approved treatment for multiple myeloma.
  • An overall response rate (ORR) of 61.8% was achieved, notably with 28.2% of patients achieving a complete response (CR) or better (CR or stringent complete response [sCR]) in pivotal Phase 2 MajesTEC-1 trial.
  • The approval, however, comes with a boxed warning for cytokine release syndrome, a condition where the immune system reacts more aggressively than it should, and neurologic toxicity.
  • Reuters report that the drug will have a list price of $39,500 per month, with an overall pricing of around $355,000-$395,000 for a nine to the 10-month course.
  • Price Action: JNJ shares closed at $170.71 on Tuesday.
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