FDA Expands Approval of Yervoy for Metastatic Melanoma in Pediatric Patients

The FDA has expanded the indication of Bristol-Myers Squibb’s Yervoy (ipilimumab) to include the treatment of pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

Yervoy was evaluated in 2 trials—a dose-finding study with 33 patients between the ages of 2 and 21 years old with relapsed or refractory solid tumors, and an open-label, single-arm trial in 12 patients between the ages of 12 and 16 years old with previously treated or untreated, unresectable stage 3 or 5 malignant melanoma—and demonstrated equivalent safety to the use of Yervoy in adults.

“Metastatic melanoma is extremely rare in children and adolescents, which makes it particularly difficult to investigate in clinical trials,” Lia Gore, MD, University of Colorado School of Medicine and Children’s Hospital of Colorado, explained in a press release. “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.”

The approved dose in patients 12 years and older includes 3 mg/kg administered intravenously for 90 minutes every 3 weeks until 4 doses are completed.

“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,” Gore added.

This expanded approval of Yervoy is Bristol-Myers Squibb’s first pediatric indication for an immuno-oncology medicine. Yervoy has already been in use and effective for 6 years and has treated more than 38,000 adult metastatic melanoma patients. Bristol-Myers Squibb intend to continue testing investigational oncology agents for pediatric applications.

“Despite significant advancements in oncology research for adults in recent years, treatment options continue to be limited for pediatric patients with metastatic melanoma,” said Chris Boerner, PhD, president and head of US commercial operations, Bristol-Myers Squibb. “At Bristol-Myers Squibb, we are committed to providing meaningful support to the pediatric oncology community. This latest approval of Yervoy exemplifies our ongoing effort to expand the availability of therapies for younger cancer patients.”