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opdualag

Safety

Produktresumé för Opdualag på FASS

At 45.3 months' minimum follow-up:
Opdualag safety summary in treatment-naïve, advanced melanoma1*

 

*ITT-population. EU approved indication: PD-L1 <1%.

 

 

 

 

Safety_summary_one
Safety_summary_one

Note: Data are No. (%) unless otherwise specified.

*IMAEs included AEs of any grade that occurred in at least 1% of patients in the nivolumab plus relatlimab arm that were considered by investigators to be potentially immune-mediated and that met the following criteria: occurred within 100 days after the last dose (regardless of causality) and were treated with immune-modulating medication with no clear alternate cause or had an immune-mediated component.

Treatment-related deaths: Nivolumab plus relatlimab (n = 4): hemophagocytic lymphohistiocytosis, acute edema of the lung, pneumonitis, and multi-organ failure; nivolumab (n = 2): sepsis and myocarditis, and worsening pneumonia.

AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotrans-ferase; IMAE, immune-mediated adverse event.

Reference:

  1. Lipson, Evan J. et al. Nivolumab Plus Relatlimab in Advanced Melanoma: RELATIVITY-047 4-year update. European Journal of Cancer, Volume 0, Issue 0, 115547.


1425-SE-2500023 July 2025

We refer to the SmPC for full information on Opdualag®