Bristol-Myers Squibb receives EU approval for Opdivo

Bristol-Myers Squibb has announced that its PD-1 immune checkpoint inhibitor Opdivo has been approved in Europe for the treatment of advanced melanoma.

It is the first and only drug in its class to be approved by the European Commission for the treatment of both first-line and previously-treated advanced melanoma patients, regardless of BRAF status.

It follows an accelerated assessment by the Committee for Medicinal Products for Human Use, which acknowledged the drug's potential to address an unmet public health need. Opdivo has demonstrated its safety and efficacy in phase III clinical trials.

The incidence of melanoma has continued to increase in almost all European countries, with an estimated one in five patients expected to develop metastatic, or advanced, disease.

Emmanuel Blin, senior vice-president and head of commercialisation, policy and operations at Bristol-Myers Squibb, said: "We are working relentlessly and at record-breaking speed to build upon our immuno-oncology science to deliver new treatment options, with the goal of improving long-term survival for patients."

The drug is also being trialled as a treatment for other cancer types, including advanced squamous non-small cell lung cancer.