EC OKs BMS’ Opdivo for Two Additional Cancer Indications
The European Commission has approved Bristol-Myers Squibb’s Opdivo (nivolumab) monotherapy for an additional indication in advanced renal cell carcinoma (RCC) after prior therapy in adults. This approval allows for the expanded marketing of Opdivo in previously treated advanced RCC in all 28 member states of the European Union.
Opdivo is a PD-1 immune checkpoint inhibitor and currently has regulatory approval in 48 countries, including the United States, Japan, and in the European Union.
In other news, the European Commission has approved Opdivo (nivolumab) monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.The approval allows for the expanded marketing of Opdivo in previously treated metastatic NSCLC in all 28 member states of the European Union.
In the US, Opdivo is indicated for the treatment of patients with metastatic NSCLC with progression on or after platinum-based chemotherapy.