15 September 2016 - Survival advantage in BRAF V600 wild type tumour depends on gender / severe side effects more common.
The use of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) has been approved since May 2016 for adults with advanced melanoma. The German IQWiG examined in a dossier assessment whether this drug offers an added benefit.
According to the findings, treatment-naive patients with BRAF V600 mutation-negative tumour survive longer. This advantage differs by gender, however. At the same time, severe side effects are more common under nivolumab in combination with ipilimumab. Overall, IQWiG sees an indication of considerable added benefit in men, and a hint of a non-quantifiable added benefit in women.
The dossier contained no evaluable data for further patient groups.