Bristol-Myers Squibb receives CHMP recommendation for Opdivo approval

Bristol-Myers Squibb has announced that its drug Opdivo has been recommended for approval in Europe for the treatment of advanced melanoma.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending that the PD-1 immune checkpoint inhibitor be approved for first-line and previously treated patients with advanced melanoma.

This is the first positive opinion given by the CHMP for a drug in this category, with the decision now set to be reviewed by the European Commission over the coming weeks.

Opdivo was granted accelerated assessment status based on its ability to meet a major public health need. It has demonstrated its safety and efficacy in phase III clinical trials.

Michael Giordano, senior vice-president and head of development for oncology at Bristol-Myers Squibb, said: "We are pleased with today's CHMP positive opinion, as it is a step closer to us bringing this important medicine for those advanced melanoma patients in Europe in need of new options."

The company is also evaluating Opdivo as a treatment for several other cancer types, including lung cancer.