EMA Advisory Committee Recommends New Uses for BMS’ Cancer Drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Bristol-Myers Squibb’s 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.
The CHMP positive opinions will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Opdivo is already approved by the EC for advanced melanoma and previously treated advanced squamous NSCLC.
In the US, Opdivo is approved for the treatment of patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. It is also approved for advanced RCC who have received prior anti-angiogenic therapy.
Source: Bristol-Myers Squibb
