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.
Bristol-Myers Squibb Oncology development head Fouad Namouni said: “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.
“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.
Elbe Klinikum Buxtehude Department of Dermatology chief physician and Skin Cancer Center Buxtehude head Peter Mohr said: “While pediatric melanoma is rare, more effective therapeutic approaches are needed for this patient population.
“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.