6 April 2016 - Bristol-Myers Squibb Company announced today that the European Commission has approved Opdivo (nivolumab) monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Opdivo is the only approved PD-1 inhibitor to demonstrate superior overall survival (OS) in two separate Phase 3 trials in previously treated metastatic NSCLC; one trial in squamous NSCLC (CheckMate -017) and the other in non-squamous NSCLC (CheckMate -057), the basis of this approval. Together, these trials confirm the benefit of Opdivo for patients with previously treated metastatic NSCLC, regardless of PD-L1 expression. The approval allows for the expanded marketing of Opdivo in previously treated metastatic NSCLC in all 28 Member States of the European Union.
For more details, go to: http://news.bms.com/press-release/european-commission-approves-expanded-use-opdivo-nivolumab-include-previously-treated-&t=635955562708618086