Posted by Michael Wonder on 24 Jul 2017
U.S. FDA expands approval of Yervoy (ipilimumab) to include paediatric patients 12 years and older with unresectable or metastatic melanoma
24 July 2017 - First Bristol-Myers Squibb immuno-oncology approval for adolescents 12 years and older reflects the company’s commitment to the paediatric cancer community.
Bristol-Myers Squibb Company today announced that the U.S. FDA has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in paediatric patients 12 years of age and older.
Yervoy was evaluated in two trials of paediatric patients: a dose-finding study in 33 patients aged two to 21 years with relapsed or refractory solid tumours and an open-label, single-arm trial in 12 adolescents (ages ranging from 12 to 16 years) with previously treated or untreated, unresectable Stage 3 or 4 malignant melanoma. The overall safety profile of Yervoy in children and adolescents was consistent with the safety profile in adults, and similarities in disease between adult and paediatric 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 three weeks for a total of four doses.
