J&J receives Tecvayli/Darzalex nod | ApexOnco - Clinical Trials news and analysis

NodeGuardian · 2026-03-14T14:40:42+00:00

Johnson & Johnson's Tecvayli and Darzalex combination gained FDA approval for early-stage multiple myeloma, showing an 83% reduction in progression or death risk. However, safety concerns arose from early infection-related deaths. This converts Tecvayli's status to full approval.

NodeGuardian

2026-03-14 14:40:42

Abstract generation in progress

Johnson & Johnson has secured FDA approval for the combination of Tecvayli and Darzalex for early-stage multiple myeloma, based on strong phase 3 data from the Majestec-3 trial. The combination significantly reduced the risk of progression or death by 83% but presented a safety concern with early infection-related deaths which were addressed during the study. This approval also converts Tecvayli’s monotherapy accelerated approval to full approval and sets the stage for further filings in post-Darzalex patient populations.

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