EU approves Opdivo (nivolumab) to treat renal cell carcinoma.- BMS

Bristol-Myers Squibb Company announced that the European Commission has approved Opdivo (nivolumab) monotherapy for an additional indication in advanced renal cell carcinoma (RCC) after prior therapy in adults. Opdivo is the first and only PD-1 immune checkpoint inhibitor approved in Europe to demonstrate an overall survival (OS) benefit versus a standard of care in this patient population. This approval allows for the expanded marketing of Opdivo in previously treated advanced RCC in all 28 Member States of the European Union.

This approval is based on the results of the Phase III study CheckMate -025, which were published in The New England Journal of Medicine. In CheckMate -025, Opdivo was evaluated in patients with advanced clear-cell RCC who received prior anti-angiogenic therapy compared to everolimus. Patients treated with Opdivo achieved a median OS of 25 months versus 19.6 months for everolimus (HR=0.73 [98.5% CI: 0.57-0.93; p=0.0018]), representing a greater than five month improvement over a current standard of care. CheckMate -025 also evaluated patients’ quality of life (QoL) and found that patients treated with Opdivo had improved survival and QoL compared to everolimus throughout the duration of treatment.