Bristol-Myers Squibb Company (NYSE:BMY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Yervoy (ipilimumab) for pediatric patients 12 years of age and older who have unresectable or metastatic melanoma.
The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
“Pediatric melanoma is a particularly rare cancer, with limited treatment options for children in the EU impacted by the disease,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “We are pleased with today’s positive CHMP opinion and look forward to hearing from the EC, as we continue to develop and deliver new therapies for the pediatric cancer community.”
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 U.S. Food and Drug Administration (FDA) expanded the approval of Yervoy to include pediatric patients 12 years and older in July 2017.