FDA and EMA accept Bristol-Myers’ filing for expanded Opdivo indications

The projected FDA’s action date is 11 November, while the EMA's centralized review process is underway.

The data supporting both applications were generated in the phase 3 Checkmate-141 study in which Opdivo (nivolumab) met its primary endpoint of overall survival, compared to investigator’s choice of therapy.

Bristol-Myers Squibb global clinical research lead for oncology Jean Viallet said: “Squamous cell carcinoma of the head and neck that progresses after platinum therapy is a devastating disease with a poor prognosis and has had very few treatment advancements in nearly a decade.

“Based on findings from CheckMate -141, Opdivo is the first and only PD-1 inhibitor to show an overall survival benefit in a Phase 3 trial in these patients.”

Opdivo targets the cellular pathway known as PD-1/PD-L1 proteins identified on the body's immune cells and various cancer cells. The blocking of the pathway helps the body's immune system fight cancer cells.

Opdivo was the first PD-1 immune checkpoint inhibitor to secure regulatory approval anywhere in the world in July 2014. It is currently approved in 53 countries including the US, Japan, and in the European Union.

It is claimed to be the only immuno-oncology agent to secure eight approvals in less than two years in four different cancer types, including three solid tumors and now expanding to a hematologic malignancy.

In May this year, the FDA granted accelerated approval for Opdivo to treat patients with classical Hodgkin lymphoma.

Image: Bristol-Myers Squibb’s facility in New Brunswick, New Jersey, US. Photo: courtesy of Bristol-Myers Squibb Company.