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news.The European Medicines Agency (EMA) has validated Bristol-Myers Squibb's type II variation application seeking approval for the use of Opdivo (nivolumab) in previously treated advanced renal cell carcinoma (RCC).
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The company plans to extend the existing indication for Opdivo to include the treatment of adult patients with advanced RCC after prior therapy.
Validation confirms that the application is complete and the review process is underway.
Under the Phase 3 Checkmate-025 study, Opdivo demonstrated superior overall survival in patients with metastatic kidney cancer.
Bristol-Myers Squibb senior vice president and head of development for oncology Michael Giordano said: "Europe has one of the highest incidence rates of renal cell carcinoma, and a significant percentage of these patients are diagnosed at an advanced stage of the disease.
"The validation of our application by the EMA is an important step in the regulatory review process in the European Union, and we will continue to work with the utmost speed to bring Opdivo to patients with this cancer."
The US Food and Drug Administration has recently approved Opdivo to treat patients with metastatic non-small cell lung cancer.
Opdivo currently has regulatory approval in over 37 countries including Japan and the European Union.
Bristol-Myers has enrolled over 8,000 patients globally to study Opdivo in multiple tumor types featuring more than 50 trials as monotherapy or in combination with other therapies.