FDA expands approval of Yervoy

The US Food and Drug Administration has expanded the indication for blockbuster cancer drug 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.

US pharma major Bristol-Myers Squibb’s (NYSE: BMY) 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 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 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 3mg/kg, administered intravenously over 90 minutes every three weeks for a total of four doses.

In 2016, Yervoy reported revenues of around $1.1 billion, which represents a ~6% year-over-year rise. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.