Bristol-Myers Squibb receives EU approval for combination melanoma therapy

Bristol-Myers Squibb has announced that its drug Opdivo has been approved in combination with Yervoy for the treatment of advanced melanoma.

Following approval from the European Commission, it becomes the first and only approved combination of two immuno-oncology agents in the EU.

Approval was based on positive findings from the phase III clinical trial CheckMate -067, which showed that Opdivo plus Yervoy and Opdivo monotherapy offered superior progression-free survival and objective response rates versus Yervoy alone.

The safety profile was consistent with previously reported studies, with most treatment-related adverse events managed using established algorithms.

Emmanuel Blin, senior vice-president and head of commercialisation, policy and operations at Bristol-Myers Squibb, said: "Today's approval of the Opdivo and Yervoy Regimen for advanced melanoma patients supports our goal of developing innovative treatment approaches that have the potential to improve patient outcomes."

This comes after Bristol-Myers Squibb and AbbVie also received EU approval for Empliciti for the treatment of multiple myeloma earlier this week.