The European Medicines Agency (EMA) has validated Bristol-Myers Squibb’s (BMS) type II variation application for expansion of existing indications for Opdivo (nivolumab) and Yervoy (ipilimumab).

Through the application, BMS is seeking to use the combination therapy for the treatment of advanced renal cell carcinoma (RCC) patients who are at intermediate and poor-risk.

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Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor developed to leverage the immune system of the body to aid in the restoration of anti-tumour immune response.

Yervoy is a monoclonal antibody designed to target the CTLA-4 protein receptor for stimulating the immune system.

Bristol-Myers Squibb executive vice-president and chief commercial officer Murdo Gordon said: “Renal cell carcinoma accounts for more than 100,000 deaths worldwide each year, and for untreated patients who have an advanced form of the disease, there are few treatment options available in the European Union.

“Renal cell carcinoma accounts for more than 100,000 deaths worldwide each year.”

“The validation of this application for the Opdivo plus Yervoy combination attests to our commitment to bring immuno-oncology treatment to as many patients as possible, especially those with a great unmet need, including patients with RCC.”

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The validation marks the beginning of the EMA centralised review process of the application, which is based on results obtained during the Phase III CheckMate-214 trial.

As per the results, the randomised, open-label Phase III trial met the co-primary endpoints of improved overall survival and objective response rate.

The trial compared the combination therapy, 3mg/kg of Opdivo plus 1mg/kg of Yervoy, with 50mg of sunitinib in previously untreated advanced or metastatic RCC patients.