BMS Receives Positive CHMP Opinion in the EU for Nivolumab

Bristol-Myers Squibb (BMS) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that nivolumab, an investigational PD-1 immune checkpoint inhibitor, be granted approval for use in both first-line and previously treated  patients with advanced (unresectable or metastatic) melanoma. This is the first positive opinion given by the CHMP for a PD-1 immune checkpoint inhibitor, and it will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).

The EMA granted BMS accelerated assessment of nivolumab based on current regulations that fulfil its guidance about “medicinal products…of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation...”.

“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,” said Michael Giordano, senior vice president, Head of Development, Oncology, at BMS. “Our vision is to transform how we approach cancer — from clinical practice to improved patient outcomes. We continue to expand the breadth and depth of our immuno-oncology portfolio across the continuum of melanoma and multiple other cancers, with the goal of providing more patients with the opportunity for long-term survival.”