The drug is already approved in Europe for use in previously treated patients with metastatic squamous NSCLC.
Opdivo’s indication has now been expanded to include non-squamous NSCLC, which represents 85% of lung cancer cases, and monotherapy for locally advanced or metastatic disease.
The approval is based on results from the phase 3 CheckMate-057 trial, which compared nivolumab with docetaxel in patients with metastatic non-squamous NSCLC.
Nivolumab demonstrated better overall survival than docetaxel, with a 27% reduction in the risk for death. The median overall survival was 12.2 months with nivolumab and 9.4 months with docetaxel.
The company said Opdivo is the only PD-1 inhibitor that has been approved for a range of patients with previously treated metastatic NSCLC, regardless of PD-L1 expression, and it is also the only approved PD-1 inhibitor to demonstrate a better overall survival compared docetaxel in previously treated metastatic NSCLC.
The European Commission has also granted approval for the use of Opdivo in adults with advanced renal cell carcinoma (RCC) after previous therapy.
The approval is based on results from the phase 3 CheckMate-025 study, which compared Opdivo with everolimus in patients with advanced clear-cell RCC who had received previous antiangiogenic therapy.
Patients treated with nivolumab achieved a median overall survival of 25 months, compared with 19.6 months with everolimus.
Image: Bristol-Myers Squibb building in New Brunswick, New Jersey, US. Photo: courtesy of Bristol-Myers Squibb Company.