UK Regulators Perceive Value of Nivolumab in RCC

Patients with advanced kidney cancer in the UK now have access to nivolumab through an early access scheme.

Patients with advanced renal cell carcinoma (RCC)—the 8th most common cancer in the UK—will now have access to nivolumab ahead of a licensing decision in Europe. UK’s Medicines and Healthcare Regulatory Products Agency announced the inclusion of nivolumab in the Early Access to Medicines Scheme, which lends patients access to drugs before they are officially approved.

Patients with RCC usually present with advanced disease when first diagnosed (27% in the UK), of which just 15% of men and 10% of women will survive for 5 years or more; this presents a huge unmet need in the population.

The international phase 3 trial of nivolumab in patients with RCC, Checkmate-025, recruited patients from across 24 countries. The trial was stopped early based on advice from an independent Data Monitoring Committee following results from the phase 3 study—a significant increase in median overall survival of 5.4 months was observed in previously-treated patients with RCC who were administered nivolumab, compared with those treated with everolimus

Nivolumab was only recently approved by the FDA for treating patients with advanced RCC who had progressed on prior therapy. When announcing the approval, Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said, “Opdivo’s extended indication, from melanoma and non-small cell lung cancer to renal cell cancer, demonstrates how immune therapies can benefit patients across a wide range of tumors.”