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.
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