At the beginning of October, the Food and Drug Administration (FDA) approved Nivolumab (Opdivo) as an adjuvant treatment for patients (12 years and over) diagnosed with early stage melanoma (without lymph node involvement), following complete resection of the tumor with surgical safety margins.

Opdivo - as well as Keytruda, which had been previously approved for these patients – is an immunotherapy drug. Both drugs have the same mechanism of action by which they enhance the ability of the immune system to fight and destroy cancer cells.

The approval is supported by the results of a clinical trial in which 790 patients, meeting the abovementioned criteria, were randomly assigned to receive either Opdivo every 4 weeks for up to a year (study group), or placebo on the same schedule (control group).

After follow-up of about 5 years, the results pointed towards a significant lower risk of disease recurrence among the study group patients receiving Opdivo, compared to the control group patients receiving placebo.

The researchers believe that the addition of Opdivo following complete resection of the tumor in early stage melanoma patients, increases the potential for better long-term outcomes among these patients.