Bristol-Myers Squibb Co., announced that the European Commission (EC) has expanded the indication of Yervoy (ipilimumab) to include treatment of advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older. The EC approval marks Bristol-Myers Squibb’s first pediatric indication for an Immuno-Oncology medicine in the European Union (EU) and allows for the marketing of Yervoy for this indication in all 28 Member States of the EU.
“The expanded EU indication of Yervoy for pediatric patients with unresectable or metastatic melanoma is an outcome of Bristol-Myers Squibb’s unyielding commitment to advancing treatments for patients with unmet clinical needs,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “With this approval, we’re able to provide an alternative to young patients whose treatment options have traditionally been limited.”
Yervoy has been evaluated in pediatric and adolescent patient populations across two clinical trials: 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.
“While pediatric melanoma is rare, more effective therapeutic approaches are needed for this patient population,” said Peter Mohr, M.D., chief physician for the Department of Dermatology at Elbe Klinikum Buxtehude and head of Skin Cancer Center Buxtehude. “This approval of Yervoy in the EU expands physicians’ options for pediatric patients with advanced melanoma to include an Immuno-Oncology treatment.”
The U.S. Food and Drug Administration (FDA) approved Yervoy to treat pediatric patients 12 years and older with unresectable or metastatic melanoma in July 2017.
About the Yervoy Studies in Pediatric Patients
In the dose-finding trial in patients with relapsed or refractory solid tumors, the median patient age was 13 years, and 20 of the patients were 12 years of age or older. Yervoy was administered at doses of 1, 3, 5 and 10 mg/kg intravenously over 90 minutes every three weeks for four doses and then every 12 weeks thereafter until progression or treatment discontinuation.
In the open-label, single-arm trial in previously treated or untreated, unresectable Stage III or IV malignant melanoma, patients received Yervoy 3 mg/kg (four patients) or 10 mg/kg (eight patients) intravenously over 90 minutes every three weeks for four doses. Of the 12 patients 12 years of age and older with melanoma treated with Yervoy across both studies, two patients experienced objective responses, including one partial response that was sustained for more than one year.
The use of Yervoy in this age group is also supported by evidence from adequate and well-controlled studies of Yervoy in adults and population pharmacokinetic data demonstrating that the exposure at a dose of 3 mg/kg in the pediatric and adult populations is comparable. In addition, the tumor biology and the course of advanced melanoma is sufficiently similar in adults and pediatric patients 12 years and older to allow extrapolation of data from adults to pediatric patients.
The approved dose for Yervoy in pediatric patients with unresectable or metastatic melanoma is 3 mg/kg, administered intravenously over 90 minutes every three weeks for a total of four doses.