Categorized | Melanoma News, Regulatory

Ipilimumab Approaches EU Approval for Pediatric Melanoma

Source: OncLive, December 2017

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of ipilimumab (Yervoy) for the treatment of pediatric patients aged 12 years and older with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor.
The application is based on data across 2 trials in which objective responses were observed in 2 of 17 patients aged ?12 years with advanced melanoma. The responses included 1 partial response that lasted for 16 months. The European Commission (EC) will now review the application and make its final decision. According to BMS, the CHMP recommendation is its first positive opinion for an immuno-oncology agent in the pediatric setting.
“Pediatric melanoma is a particularly rare cancer, with limited treatment options for children in the EU impacted by the disease,” Murdo Gordon, executive vice president and chief commercial officer, BMS, said in a press release. “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.”