Based on new data, IQWiG finds extra added benefit for Opdivo

The German Institute for Quality and Efficiency in Health Care (IQWiG) had examined the revised added benefit dossier from US pharma major Bristol-Myers Squibb (NYSE: BMY) for Opdivo (nivolumab), which has been approved since June 2015 for adults with advanced melanoma.

In an addendum, the Institute now assessed study data subsequently submitted by the drug manufacturer in the commenting procedure. In treatment-naive patients whose tumor is BRAF V600 mutation-negative, the IQWiG still sees a hint of an added benefit in comparison with the appropriate comparator therapy for women, and an indication of an added benefit for men. The extent of the added benefit increased, however: from “minor” to “considerable” in women, and from “considerable” to “major” in men.

Additional analyses on side effects