Nivolumab (Opdivo) has received approval for 2 new indications from the European Commission.
Nivolumab is an programmed death receptor-1 (PD-1) immune checkpoint inhibitor that activates the immune system’s T cells to detect and attack cancer cells. The drug is already approved in Europe for use in previously treated patients with metastatic squamous non-small-cell lung cancer (NSCLC). Now the indication has been expanded to include non-squamous NSCLC, which represents 85% of the cases of lung cancer, and renal cell carcinoma (RCC).
Nivolumab is the first and only PD-1 inhibitor for the treatment on RCC approved by the European Commission. The approval is based on results from the phase 3 CheckMate-025 study, which were presented last year.
This trial compared nivolumab 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 25.0 months, compared with 19.6 months with everolimus, representing a greater than 5 month improvement over a current standard of care.