Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the European Commission (EC) as an adjuvant treatment in adults and adolescents with completely resected stage 2B or 2C melanoma.
The decision makes Opdivo, which is already approved in the EU for use in certain melanoma patients, the only PD-1 inhibitor authorised as an adjuvant treatment for patients within stages 2B, 2C and 3, as well as stage 4 resected melanoma.
The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.
Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses.
The EC’s latest approval for Opdivo, which follows a recommendation from the European Medicines Agency’s human medicines committee, was supported by positive safety and efficacy results from the phase 3 CheckMate-76K trial, in which the therapy reduced the risk of recurrence or death by 58% versus placebo at a minimum follow-up of 7.8 months.
“Patients with stage 2B or 2C melanoma are at a high risk of disease recurrence following surgery. This can be a very impactful event for patients,” explained Peter Mohr, chief physician and head of the Skin Cancer Center, Buxtehude, in the Department of Dermatology at Elbe-Kliniken in Germany.
He continued: “This approval reinforces the benefit that [Opdivo] may offer when used after resection, potentially preventing the disease from recurring.”
Opdivo is a PD-1 immune checkpoint inhibitor that is designed to utilise the body’s own immune system to help restore an anti-tumour immune response.
The therapy is currently approved in more than 65 countries, including the US, EU, Japan and China, for a range of indications such as lung, kidney and gastric cancers.
Gina Fusaro, vice president, global programme lead at BMS, said: “With this approval, we can now offer patients in the EU with stage 2B or 2C resected melanoma an efficacious treatment option that significantly reduces the risk of disease recurrence.”