This article is more than 5 years old. Information may no longer be current.
FDA expands indication of Yervoy to include pediatric patients with melanoma
Click Here to Manage Email Alerts
The FDA expanded the indication of ipilimumab to include the treatment of unresectable or metastatic melanoma in patients aged 12 years or older, according to the drug’s manufacturer.
“Metastatic melanoma is extremely rare in children and adolescents, which makes it particularly difficult to investigate in clinical trials. Although 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, pediatrician at University of Colorado School of Medicine and Children’s Hospital of Colorado, said in a company-issued release. “Ipilimumab’s [Yervoy, Bristol-Myers Squibb] 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.”
Two trials evaluated the safety and efficacy of ipilimumab — a recombinant, human monoclonal antibody that binds to CTLA-4 — in pediatric patients.
A dose-finding study evaluated ipilimumab in 33 patients aged 2 to 21 years (median age, 13 years) with relapsed or refractory solid tumors. Patients received 1 mg/kg, 3 mg/kg, 5mg/kg or 10 mg/kg IV ipilimumab over 90 minutes every 3 weeks for four doses, followed by every 12 weeks thereafter until disease progression or treatment discontinuation.
An open-label, single-arm trial evaluated ipilimumab in 12 pediatric patients aged 12 years and older with previously treated or untreated, unresectable stage III or stage IV malignant melanoma. Patients received 3 mg/kg or 10 mg/kg IV ipilimumab over 90 minutes every 3 weeks for four doses.
Of the 17 patients aged 12 years and older across both studies, two patients experienced objective responses, including one partial response that persisted for 16 months.
The overall safety profiled appeared consistent with previous studies of ipilimumab.
The most common severe immune-mediated adverse events associated with ipilimumab include enterocolitis, hepatitis, dermatitis, neuropathy and endocrinopathy.
The approved dose for ipilimumab in pediatric patients with unresectable or metastatic melanoma is 3 mg/kg, administered intravenously over 90 minutes every 3 weeks for a total of four doses.
“Despite significant advancements in oncology research for adults in recent years, treatment options continue to be limited for pediatric patients with metastatic melanoma,” Chris Boerner, PhD, president and head of U.S. commercial operations at Bristol-Myers Squibb, said in the release. “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.”