At the beginning of December, the Food and Drug Administration approved Pembrolizumab (Keytruda) - an immunotherapy drug - for adjuvant treatment of adult and pediatric patients (12 years of age and above) who were diagnosed with cutaneous melanoma without lymph node involvement (stage IIB or IIC), following complete resection of the tumor.

The approval is supported by results from a clinical trial in which close to 1,000 patients with completely resected cutaneous melanoma and no lymph node involvement were randomly assigned to receive either immunotherapy with Pembrolizumab (those allocated to the study group) every three weeks for up to one year, or placebo (those allocated to the control group).

After follow-up of approximately one year, a significant lower risk of disease recurrence (35%) was observed among patients in the study group who received Pembrolizumab, compared to the control group who received placebo (HR=0.65; P=0.0132).

From a safety and adverse events standpoint, the study showed the Pembrolizumab group to have a manageable safety profile, and no deaths were associated with adverse events.

The approval of Pembrolizumab for adjuvant treatment offers healthcare providers the opportunity to help prevent melanoma recurrence in high risk melanoma patients 12 years and older.