The FDA has expanded the indication for ipilimumab injection for IV use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older.
Ipilimumab was evaluated in two trials of pediatric patients: a dose-finding study in 33 patients ages 2-21 years with relapsed or refractory solid tumors, and an open-label, single-arm trial in 12 adolescents (ages ranging from 12-16 years) with previously treated or untreated, unresectable stage III or IV malignant melanoma.
The overall safety profile of ipilimumab in children and adolescents was consistent with the safety profile in adults, and similarities in disease between adult and pediatric patients 12 years and older allow for extrapolation of data. Based on a population pharmacokinetic analysis, exposure in adolescents 12 years and older is comparable to that in adults for the approved dose of 3 mg/kg, administered intravenously over 90 minutes every 3 weeks for a total of four doses.
Ipilimumab can result in severe to fatal immune-mediated adverse reactions. These reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy.