Bristol-Myers Squibb has obtained approval from the European Commission (EC) for its Opdivo (nivolumab) for previously treated advanced renal cell carcinoma (RCC).
RCC is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year.
Opdivo is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells, and blocks the binding of PD-L1 and PD-L2.
It prevents the PD-1 pathway’s suppressive signalling on the immune system, including the interference with an anti-tumour immune response.
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Said to be the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, Opdivo currently has regulatory approval in 48 countries including the US, Japan, and in the European Union.
Bristol-Myers Squibb commercialisation, policy and operations head Emmanuel Blin said: "Today’s approval is reflective of our commitment to bring Opdivo and the potential for long-term survival to broad patient populations, including previously treated advanced renal cell carcinoma."
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The approval is based on the Phase III study CheckMate -025, in which Opdivo was evaluated in patients with advanced clear-cell RCC who received prior anti-angiogenic therapy compared to everolimus.
Clear-cell RCC is the most prevalent type of RCC and constitutes 80% to 90% of all cases.
Genitourinary Oncology Committee chair Dr Bernard Escudier said: "For the first time, previously treated advanced renal cell carcinoma patients in Europe will now have access to an Immuno-Oncology agent that has demonstrated a significant overall survival benefit along with a favourable safety profile compared to everolimus.
"In addition to the clinical efficacy results, patients treated with Opdivo experienced an improvement in their health-related quality of life and had significantly lower symptom burden throughout treatment compared to patients receiving everolimus."
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