CHMP recommends Opdivo (nivolumab) for metastatic melanoma.-BMS

Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that 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).

Comment: Opdivo is already approved for metastatic melanoma following Yervoy (ipilimumab) and if BRAF mutation positive, a BRAF inhibitor. Yervoy is the current standard of care for this condition but likely to be replaced with better efficacy and less toxic side effects by Opvivo and Keytruda (pembrolisumab) from Merck Inc.