EC approves Opdivo in NSCLC and advanced kidney cancer

The European Commission has granted approval for the use of Bristol-Myers Squibb’s Opdivo (nivolumab) to treat patients with the most common forms of advanced lung and advanced kidney cancer.

This significantly broadens the current label for nivolumab to include the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy, in addition to adult patients with advanced renal cell carcinoma (RCC) who have received prior therapy.

This approval expands nivolumab’s existing lung cancer indication so it can now be used to treat both metastatic squamous NSCLC and non-squamous NSCLC patient populations, which together represent 85% of lung cancer cases. Nivolumab is the only PD-1 inhibitor approved in Europe to demonstrate superior overall survival in locally advanced or metastatic NSCLC. It is approved for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy regardless of PDL1 status.

Commenting on the implications for advanced lung cancer patients, Professor Dean Fennell, Chair of Thoracic Medical Oncology, University of Leicester, said: “The survival outlook for patients with this cancer is very poor once the disease has spread. Until today, chemotherapy has been the main option, offering limited benefits and significant side effects. The launch of nivolumab will irrevocably change the treatment of this condition and represents one of the biggest advances in almost two decades. Treating these patients as quickly as possible is vital so we hope access will be as prompt as possible across the UK.”

First PD-1 inhibitor approved for advanced kidney cancer

Nivolumab is also the first PD-1 inhibitor therapy approved to treat advanced kidney cancer patients who have received prior therapy. In addition, it is the first medicine to demonstrate a significant improvement in overall survival in advanced kidney cancer compared to current standard therapy, everolimus.

Commenting on the impact of this decision for kidney cancer patients, Dr. Samra Turajlic, Consultant Medical Oncologist, The Royal Marsden, said: “In the UK, the incidence of kidney cancer has more than doubled over the last 30 years and the outlook for patients with advanced stages of this disease can be very poor, with few patients surviving beyond five years. A particular area of unmet clinical need are those patients whose cancer has become resistant to standard first or second line therapy with VEGF inhibitors. In this setting, nivolumab is the first immunotherapy to demonstrate in a clinical trial, significant improvement in kidney cancer survival compared to standard therapy, whilst causing fewer side effects.”