publication date: Jul. 28, 2017

Drugs and Targets

FDA expands approval of Yervoy to include pediatric patients 12 years and older with unresectable or metastatic melanoma

Bristol-Myers Squibb Co. said FDA has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older.

Yervoy was evaluated in two trials of pediatric patients: a dose-finding study in 33 patients aged two to 21 years with relapsed or refractory solid tumors and an open-label, single-arm trial in 12 adolescents (ages ranging from 12 to 16 years) with previously treated or untreated, unresectable stage III or IV 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 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 three weeks for a total of four doses.

The FDA approval for Yervoy in patients 12 years and older with metastatic melanoma marks Bristol-Myers Squibb’s first pediatric indication for an immuno-oncology medicine. The expanded indication builds upon six years of experience with Yervoy, which has been used to treat more than 38,000 adult patients with metastatic melanoma since its first approval.

Yervoy has been evaluated in a total of 45 pediatric patients across two clinical trials. The safety and effectiveness of Yervoy have been established in pediatric patients 12 years and older.

The use of Yervoy in this age group is supported by evidence from adequate and well-controlled studies of Yervoy in adults and population pharmacokinetic data … Continue reading FDA expands approval of Yervoy to include pediatric patients 12 years and older with unresectable or metastatic melanoma

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