UK's NICE Rejects Johnson & Johnson's Darzalex Regime For Newly Diagnosed Myeloma

  • New guidance from the National Institute for Health and Care Excellence (NICE) has rejected a combination regimen based on Johnson & Johnson's JNJ Darzalex for previously untreated patients with multiple myeloma.
  • The draft document covers the use of Darzalex (daratumumab) as an add-on to standard induction treatment with Takeda Pharmaceutical Co Ltd's TAK Velcade (bortezomib) plus thalidomide and dexamethasone given to patients before a stem cell transplant. 
  • The regimen's long-term benefits were unclear, NICE said. 
  • Also, J&J's economic model didn't incorporate Bristol Myers Squibb & Co's BMY Revlimid (lenalidomide) as maintenance therapy after transplant.
  • NICE reviewers noted that maintenance treatment with Revlimid has recently become standard for front-line myeloma post-transplant. J&J's economic model included the costs of Revlimid but not the benefits because no clinical data is available evaluating Revlimid maintenance after Darzalex consolidation therapy.
  • NICE has opened the evaluation to comments until September 17 and plans to hold another appraisal committee meeting on November 4 to publish a final decision by January 12, 2022.
  • Related content: Benzinga's Full FDA Calendar
  • Price Action: JNJ shares are down 0.04% at $172.86 during the premarket session on the last check Monday.
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