Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA) as an adjuvant treatment for adults and adolescents aged 12 years and older with completely resected stage 2B or 2C melanoma.

The decision makes Opdivo, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely 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 more than 97,000 new cases expected to be diagnosed in the US overall this year.

Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses.

“Within five years of diagnosis, one-third of patients with surgically resected stage 2B and nearly one-half of patients with surgically resected 2C melanoma see their cancer return, underscoring the need for additional treatment options that may help reduce the risk of cancer coming back,” said John Kirkwood, professor of medicine at the University of Pittsburgh School of Medicine and co-director of the Melanoma Center at UPMC Hillman Cancer Center in Pittsburgh, US.

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 FDA's latest approval for Opdivo is supported by positive safety and efficacy results from the late-stage CheckMate-76K trial, in which the therapy reduced the risk of recurrence or death by 58% versus placebo.

Catherine Owen, senior vice president and general manager, US cardiovascular, immunology and oncology at BMS, said: "This approval builds on our existing adjuvant indication in completely resected stage 3 or 4 disease and now provides eligible patients with completely resected stage 2B or 2C melanoma an additional treatment option which may help prevent recurrence."

Opdivo 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.

https://www.pmlive.com/pharma_news/bristol_myers_squibbs_opdivo_approved_by_fda_for_expanded_melanoma_use_1501883