Survival advantage for treatment-naive patients with BRAF V600 wt tumor / no evaluable data available for other patient groups.

​Nivolumab (trade name: Opdivo) has been approved since June 2015 for adults with advanced melanoma. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this drug offers an added benefit over the appropriate comparator therapy.

According to the findings, treatment-naive patients with BRAF V600 mutation-negative tumour have an advantage in overall survival. This advantage varies by sex, however. Overall, IQWiG sees an indication of considerable added benefit in men, and a hint with the extent “minor” in women.

Overall, there is an added benefit of nivolumab only in treatment-naive patients with BRAF V600 wt tumor. The results on side effects are uncertain, and it is therefore not possible to balance benefit and harm. But there is no sign that a negative effect in side effects could completely outweigh the positive effect in overall survival. IQWiG therefore sees an indication of considerable added benefit of nivolumab in comparison with dacarbazine in men, and a hint of a minor added benefit in women.