Bristol-Myers Squibb receives positive opinion from CHMP for Opdivo for advanced melanoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Bristol-Myers Squibb’s Opdivo (nivolumab), a 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 Bristol-Myers Squibb accelerated assessment of Opdivo based on current regulations that fulfils its guidance about “medicinal products of major interest from the point of view of public health and in particular from the view point 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. “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, to provide more patients with the potential opportunity for long-term survival.”

Positive opinion based on CheckMate -066 and -037 studies of Opdivo

The CHMP positive opinion is based on data from two Phase III studies (CheckMate -066 and -037), demonstrating the efficacy and safety of Opdivo in advanced melanoma patients with important unmet needs. CheckMate -066, a Phase III randomised double-blind study, comparing Opdivo to the chemotherapy dacarbazine (DTIC) in patients with treatment-naïve advanced melanoma, is the first Phase III trial of an investigational PD-1 immune checkpoint inhibitor to demonstrate an overall survival benefit in advanced melanoma, as well as a higher objective response rate. A second study, CheckMate -037, is a Phase III randomised, controlled open-label study of Opdivo versus investigator’s choice chemotherapy in patients with advanced melanoma who were previously treated with Yervoy (ipilimumab), which showed improvement in objective response rates. These data are supported by a Phase Ib study (Study -003) in relapsed advanced or metastatic melanoma, which demonstrated the first characterisation of Opdivo benefit/risk in advanced melanoma. There was consistent Opdivo dosing of 3 mg/kg every two weeks across all three trials.