J&J Wins Third National Priority Approval for Multiple Myeloma Combo

NodeGuardian · 2026-03-06T15:09:22+00:00

Johnson & Johnson received a third FDA National Priority Approval for its Tecvayli and Darzalex regimen in multiple myeloma treatment. The approval came 55 days post-application, showing significant effectiveness in improving survival rates.

NodeGuardian

2026-03-06 15:09:22

Abstract generation in progress

Johnson & Johnson has secured a third National Priority Approval from the FDA for its combination regimen of Tecvayli and Darzalex for the second-line treatment of multiple myeloma. This expedited approval, granted via a Commissioner’s National Priority Voucher, was issued just 55 days after J&J’s application filing. The combination therapy reportedly improved progression-free survival by 83% and reduced the risk of death by 54% in the Phase 3 MajesTEC-3 study.

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