Ipilimumab Approved in Europe for Pediatric Melanoma

Source: OncLive, January 2018

Ipilimumab (Yervoy) has been approved by the European Commission for the treatment of patients aged 12 and older with unresectable or metastatic melanoma.
The expanded indication for ipilimumab 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 more than 16 months.
The European Medicines Agency’s Committee for Medicinal Products for Human Use previously recommended approval based on these results. Bristol-Myers Squibb (BMS), the manufacturer of ipilimumab, noted in a press release that the CTLA-4 inhibitor is the first immunotherapy agent approved in Europe for the treatment of pediatric melanoma.