CHMP recommends Opdivo (nivolumab) to treat metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and adults with advanced renal cell carcinoma.- BMS

BMS announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Opdivo (nivolumab) for two new indications – adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and adults with advanced renal cell carcinoma (RCC) after prior therapy. Both indications are supported by Phase III studies in which Opdivo demonstrated a survival benefit versus a standard of care.

The CHMP positive opinions will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Opdivo is already approved by the EC for advanced melanoma and previously treated advanced squamous NSCLC.