
Endast för hälso-och sjukvårdspersonal
Produktresumé för Opdualag på FASS
*ITT-population. EU approved indication: PD-L1 <1%.
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:
1425-SE-2500023 July 2025
We refer to the SmPC for full information on Opdualag®