Bristol-Myers Squibb has won the first paediatric indication for an immuno-oncologydrug in the US.
The Food and Drug Administration (FDA) approved an expanded licence for Yervoy (ipilimumab) that will allow its use to treat unresectable or metastatic melanoma in patients aged 12 and older.
Chris Boerner, president and head of US commercial operations, BMS, said: “Despite significant advancements in oncology research for adults in recent years, treatment options continue to be limited for paediatric patients with metastatic melanoma.
“This latest approval of Yervoy exemplifies our on-going effort to expand the availability of therapies for younger cancer patients.”
After running two trials in paediatric patients BMS found the overall safety profile for children and adolescents of Yervoy, which was first approved in the US in 2011, was consistent with that for adults.
The studies involved two groups totalling of 45 patients – one ranging from two to 21 years old and the other ranging from two to 16 – being administered a 3mg/kg dose of ipilimumab intravenously for over 90 minutes every three weeks, for a total of four doses.
Lia Gore, managing director of the University of Colorado School of Medicine and Children’s Hospital of Colorado, said: “Metastatic Melanoma is extremely rare in children and adolescents, which makes it particularly difficult to investigate in clinical trials.
“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.”
The approval comes at an essential time for the New York, US-based group, as the medicine received a knock-back from its own Opdivo (nivolumab) in adjuvant melanoma therapy, which led analysts at EvaluatePharma to predict that Merck & Co’s melanoma drug Keytruda (pembrolizumab) will topple Opdivo as the top-selling PD-1/PD-L1 inhibitor by 2022.