BRIEF—Yervoy first I-O agent to gain EU approval in certain melanoma indication

The European Commission (EC) has expanded the indication of Yervoy (ipilimumab) to include treatment of advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older.

The EC approval of the Bristol-Myers Squibb (NYSE: BMY) drug makes it the first immuno-oncology (I-O) agent to receive approval in the European Union (EU) in this patient population. It is also the first pediatric indication for an immuno-oncology medicine from the company to be approved in the EU.

Fouad Namouni, head of development, Oncology, Bristol-Myers Squibb, said: “With this approval, we’re able to provide an alternative to young patients whose treatment options have traditionally been limited.”

Approval in this indication in the USA was granted in July 2017.