Ipilimumab Approved by FDA for Pediatric Melanoma

Source: Targeted Oncology, July 2017

Ipilimumab (Yervoy) has been approved by the FDA for the treatment of patients aged greater than or equal to 12 years with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor.

The expanded indication for ipilimumab is based on data across 2 trials in which objective responses were observed in 2 of 17 patients aged greater than or equal to 12 years with advanced melanoma. The responses included 1 partial response that lasted for 16 months.

The approved ipilimumab dose for pediatric melanoma patients is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for 4 doses.

“Metastatic melanoma is extremely rare in children and adolescents, which makes it particularly difficult to investigate in clinical trials. Though designing clinical trials in small pediatric populations can be challenging, this group of investigators committed to bringing a new therapy to those in need,” Lia Gore, MD, University of Colorado School of Medicine and Children’s Hospital of Colorado, said in a statement. “Ipilimumab’s approval represents the culmination of a long effort and gives physicians the ability to expand immuno-oncology—one of the most exciting areas of medicine—for the treatment of young adults with metastatic melanoma.”